AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

Pharmaron to acquire Merck Sharpe & Dohme’s Hoddesdon research facility in UK

 companies  Comments Off on Pharmaron to acquire Merck Sharpe & Dohme’s Hoddesdon research facility in UK
Sep 302016
 

 

Pharmaron to acquire Merck Sharpe & Dohme’s Hoddesdon research facility in UK
Pharmaron has signed a non-binding heads of terms with Merck Sharpe & Dohme Limited (MSD) for the purchase of UK-based Hoddesdon site, which comprises MSD’s process development and research facility.

read at

http://www.pharmaceutical-technology.com/news/newspharmaron-to-acquire-merck-sharpe-dohmes-hoddesdon-research-facility-in-uk-5015533?WT.mc_id=DN_News

Image result for Merck Sharp & Dohme Hoddesdon research facility in UK

Image result for Merck Sharp & Dohme Hoddesdon research facility in UK

HODDESDON – Company Headquarters and Pharmaceutical Research and development Laboratories (PR&D). MSD has been present in Hoddesdon since the 1940s.

September 26, 2016 05:00 AM Eastern Daylight Time

BEIJING–(BUSINESS WIRE)–Pharmaron has entered into a non-binding Heads of Terms (HoTs) with Merck Sharpe & Dohme Limited (MSD) for the sale of the Hoddesdon UK site which includes MSD’s process development and research facility. The parties hope to complete the deal in Q1 2017.

Pharmaron and MSD agree deal to acquire MSD’s UK Hoddesdon site

Pharmaron sees this as a unique opportunity to acquire state-of-the-art Good Manufacturing Practice (GMP) standard facilities for the development of Active Pharmaceutical Ingredients (API) and formulation development in Europe to complement Pharmaron’s existing world class chemistry and integrated drug discovery and development services globally. Under the deal, MSD will remain on site on and lease-back the main office buildings.

Louise Houson, Managing Director, MSD UK and Ireland commented: “We are very pleased to be progressing this deal with Pharmaron. This deal will secure the future of the site while meeting the changing business needs of MSD and its employees for the foreseeable future. It also ensures MSD’s scientific legacy in Hoddesdon continues, with the potential to create local opportunities for our scientific staff in their areas of expertise.”

Boliang Lou, Chairman and CEO of Pharmaron commented that: “This is an exciting opportunity to have an industry-leading R&D site join the Pharmaron group, which once again demonstrates our commitment to our mission to become a world leader in small molecule drug R&D services. It allows us to develop our global capabilities in process chemistry and manufacturing services area, strengthening our capabilities in fully integrated R&D services. Together with the recent addition of GMP radiochemistry and GCP/GLP metabolism platforms through acquisition of Quotient Bioresearch in the U.K., this deal further consolidates our strategic position in Europe to better serve our partners globally, particularly in Europe.”

Commercial details on the transaction are not being disclosed.

About Pharmaron
Pharmaron is a private, premier R&D service provider for the life science industry. Founded in 2003, Pharmaron has invested in its people and facilities, and established a broad spectrum of drug R&D service capabilities, ranging from synthetic and medicinal chemistry, biology, DMPK, pharmacology, safety assessment, radiochemistry and radiolabelled metabolism to chemical & pharmaceutical development. With about 4,000 employees and operations in China, the U.S. and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China. For more information, please visit: www.pharmaron.com

Image result for pharmaron

Image result for pharmaron

Image result for pharmaron

About MSD
For 125 years, MSD has been a global healthcare leader working to help the world be well. MSD is a trade name of Merck & Co., Inc., Kenilworth, NJ., USA. Through our prescription medicines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programmes and partnerships. For more information, visit www.msd-uk.com.

//////Pharmaron,  Merck Sharpe & Dohme,  Hoddesdon research facility,  UK

Share

CDMO Ash Stevens to Be Acquired by Piramal Enterprises

 companies  Comments Off on CDMO Ash Stevens to Be Acquired by Piramal Enterprises
Aug 172016
 

STR1

 

Piramal Enterprises Limited announced that its wholly owned subsidiary in the U.S. has entered into an agreement to acquire 100 percent stake in Ash Stevens Inc., a U.S.-based contract development and manufacturing organization (CDMO), in an all cash deal for a consideration of USD $42.95 million plus an earn-out consideration capped at $10 million. This potential transaction is expected to be completed by the end of August.

Located in Riverview, Michigan, Ash Stevens has over 50 years of experience in contract manufacturing, and serves several biotech, mid-size pharma, and large pharmaceutical clients worldwide.

With over 60,000 sq. ft. of facilities, eight chemical drug development and production laboratories, and six full-scale production areas, Ash Stevens has built a stellar reputation, led by science, driven by operational excellence, and one that emphasizes quality as a culture. As one of the leaders in HPAPI manufacture, Ash Stevens has an impeccable safety record of working with high potency anti-cancer agents and other highly-potent therapeutics. The state-of-the-art manufacturing facility in Michigan features all necessary engineering and containment controls for the safe handling and cGMP manufacture of small and large-scale HPAPIs, with Occupational Exposure Limits (OELs) ≤ 0.1µg/m3. The facility has approvals from U.S., EU, Australia, Japan, Korea, and Mexico regulatory agencies.

“The acquisition of Ash Stevens fits well with our strategy to build an asset platform that offers value to our partners and collaborators. Currently, around 25 percent of the molecules in clinical development are potent. Our clients are looking for reliable partners that can assist them in advancing these programs forward,” said Vivek Sharma, CEO of Piramal Pharma Solutions. He further adds, “North America is a key market that we can now service with our three local facilities – the Coldstream Labs in Kentucky for fill finish needs, the Torcan facility in Toronto for complex high value APIs and now, Ash Stevens in Michigan for HPAPIs. Having facilities with a differentiated platform and geographical proximity to clients are keys towards building strategic partnerships. We expect this acquisition to also be synergistic with our Antibody Drug Conjugates (ADCs) and injectable business. We can now fulfill client requirements for a single source of supply for both high potent APIs and drug products.”

“With its rich history of scientific excellence, a track record of 12 product launches, Ash Stevens is well poised to become the partner of choice for clients looking to advance programs from early development through launch. In addition to the business benefits that the combined entity will bring to our clients, I am also pleased that the firms share common core values: both were founded by successful entrepreneurs, value integrity, and are committed to a customer-first approach,” said Dr. Mark Cassidy, President of the API Business at Piramal Pharma Solutions. “I am pleased to welcome the Ash Stevens team into the Piramal group. We expect them to be an integral part of our future growth plans.”

Added Dr. Stephen Munk, CEO of Ash Stevens, “We look forward to working with the Piramal leadership and management team, to develop API solutions that benefit customers and improve the lives of patients. The commitment that Piramal has shown towards growing its healthcare businesses, coupled with the complementary capabilities that our two firms have, makes this an exciting time for Ash Stevens and our employees. We have already identified areas where we can create significant value together, and will be moving forward rapidly to achieve those objectives.”

The transaction is not subject to any regulatory approvals. No related party of PEL has any interest in Ash Stevens.

Wells Fargo Securities, LLC served as exclusive financial advisor to Ash Stevens, with legal counsel provided by Morrison & Foerster LLP.

For further information on the financials, please visit our website: www.piramal.com.

Dr. Stephen A. Munk, President and CEO of Ash Stevens Inc.
Large scale reactor train with 2000, 3000, and 4000 L glass-lined reactors equipped with split butterfly valves.
Ash Stevens’ down draft kilo suite with low temperature capability.

Ajay Piramal

The Piramal family's purposeful philanthropy

From left: Anand Piramal, executive director, Piramal Group; Swati Piramal, vice-chairperson, Piramal Group; Ajay Piramal, chairman, Piramal Group; Nandini Piramal, executive director, Piramal Enterprises; and Peter DeYoung, president, Piramal Enterprises

 

////////////CDMO,  Ash Stevens, Piramal Enterprises, Stephen A. Munk

Share

Scaling up from mg to Kgs – Making your First GMP Batch

 companies, CONFERENCE  Comments Off on Scaling up from mg to Kgs – Making your First GMP Batch
Aug 032016
 

STR1

Scaling up from mg to Kgs – Making your First GMP Batch 

6th – 7th October 2016, Clearwater, USA

the course was very informative and it allowed me to see the big picture from discovery stage to pilot plant” 
Genentech

Course Outline:

  • Introduction
  • Making the first 100g non-GMP Batch
  • Non-GMP vs GMP preparation
  • Physical version and form
  • Process safety and raw materials supply
  • Scaling into fixed vessels
  • Technology transfer
  • Genotoxic impurities
  • Case studies and Review

Who should attend:

  • Project managers
  • Project leaders
  • Bench chemists
  • New starters
  • MedChem Support teams

This course aims to provide attendees with a good understanding of the issues involved taking development candidates to the first in human trials.

Click here to Download the Course Brochure

Presented by Dr John Knight, JKonsult Ltd

John Knight

Managing Director at JKONSULT Ltd

STR1
Click here to Download the Course Brochure

“Brilliant Course, learn lots of tips and tricks”
Vertex

First incursion into Chemical Development has been very, very educational. John’s way of explaining the material has been wonderful.”
Almirall

Very clear and interesting sessions with a lot of relevant examples and not only theory.” 
Oribase Pharma
LINK
LITERATURE FROM INTERNET ON HIS TOPIC
//////////Scaling up,  mg to Kgs, Making,  First GMP Batch, SCIENTIFIC UPDATE,  JOHN KNIGHT, Clearwater, USA
Share

Synmr Chemicals Pvt Ltd, the first manufacturers of NMR Solvents in India

 companies, spectroscopy, SYNTHESIS  Comments Off on Synmr Chemicals Pvt Ltd, the first manufacturers of NMR Solvents in India
Jul 202016
 
 
“Synmr Chemicals Pvt Ltd” (Formerly known as Synovation Chemicals Pvt Ltd) are the first manufacturers of NMR Solvents in India. This would benefit the Indian Science community as they no longer would have to depend on Imports, high pricing and uncertain supply.
Please do assist “Synmr” and promote our “Make in India” endeavor


Synmr Chemicals Pvt Ltd (Previously known as
Synovation Chemicals and Sourcing Pvt Ltd) is engaged in the manufacture of NMR
(Deuterated solvents).
With permission of Heavy Water Board, we can now
offer NMR Solvents manufactured in India.
 
They are the first manufactures of NMR solvents in
India and the following products have been developed and up scaled.
 
1. Chloroform D 99.8%
2.   DMSO D6 99.8%
3.   Methyl Iodide D3 99.5%
4.   Acetone D6 99.8%
5.   Acetonitrile D3 99.8%
In the Pipeline
·
Methanol
D4
·
Ethanol
D6
 





















We kindly request you to send your enquiries to

 
Suresh R Iyer
suresh@synmr.in           Contact Number +9193212 58158
dinesh@synmr.in           Contact Number +9198454 04105
Dr Sankar Iyer       sankar@synovationchemicals.in       +91 94490 63877  
Website is
www.synmr.in

nmr@synovationchemicals.in

Promote our NMR solvents and thus encourage MAKE IN INDIA.

 

 

Thanks 
Regards….?
Suresh R Iyer

————————————————————————————————————————

Team

 

INFO FROM LITERATURE OR NET

//////

Share

Sreeni Labs Private Limited, Hyderabad, India ready to deliver New, Economical, Scalable Routes to your advanced intermediates & API’s in early Clinical Drug Development Stages

 companies, INDIA, MANUFACTURING, new drugs, PRECLINICAL, PROCESS, regulatory  Comments Off on Sreeni Labs Private Limited, Hyderabad, India ready to deliver New, Economical, Scalable Routes to your advanced intermediates & API’s in early Clinical Drug Development Stages
Jul 162016
 

str1

 

Sreeni Labs Private Limited, Hyderabad, India is ready to take up challenging synthesis projects from your preclinical and clinical development and supply from few grams to multi-kilo quantities. Sreeni Labs has proven route scouting ability  to  design and develop innovative, cost effective, scalable routes by using readily available and inexpensive starting materials. The selected route will be further developed into a robust process and demonstrate on kilo gram scale and produce 100’s of kilos of in a relatively short time.

Accelerate your early development at competitive price by taking your route selection, process development and material supply challenges (gram scale to kilogram scale) to Sreeni Labs…………

INTRODUCTION

Sreeni Labs based in Hyderabad, India is working with various global customers and solving variety of challenging synthesis problems. Their customer base ranges from USA, Canada, India and Europe. Sreeni labs Managing Director, Dr. Sreenivasa Reddy Mundla has worked at Procter & Gamble Pharmaceuticals and Eli Lilly based in USA.

The main strength of Sreeni Labs is in the design, development of innovative and highly economical synthetic routes and development of a selected route into a robust process followed by production of quality product from 100 grams to 100s of kg scale. Sreeni Labs main motto is adding value in everything they do.

They have helped number of customers from virtual biotech, big pharma, specialty chemicals, catalog companies, and academic researchers and drug developers, solar energy researchers at universities and institutions by successfully developing highly economical and simple chemistry routes to number of products that were made either by very lengthy synthetic routes or  by using highly dangerous reagents and Suzuki coupling steps. They are able to supply materials from gram scale to multi kilo scale in a relatively short time by developing very short and efficient synthetic routes to a number of advanced intermediates, specialty chemicals, APIs and reference compounds. They also helped customers by drastically reducing number of steps, telescoping few steps into a single pot. For some projects, Sreeni Labs was able to develop simple chemistry and avoided use of palladium & expensive ligands. They always begin the project with end in the mind and design simple chemistry and also use readily available or easy to prepare starting materials in their design of synthetic routes

Over the years, Sreeni labs has successfully made a variety of products ranging from few mg to several kilogram scale. Sreeni labs has plenty of experience in making small select libraries of compounds, carbocyclic compounds like complex terpenoids, retinal derivatives, alkaloids, and heterocyclic compounds like multi substituted beta carbolines, pyridines, quinolines, quinolones, imidazoles, aminoimidazoles, quinoxalines, indoles, benzimidazoles, thiazoles, oxazoles, isoxazoles, carbazoles, benzothiazoles, azapines, benzazpines, natural and unnatural aminoacids, tetrapeptides, substituted oligomers of thiophenes and fused thiophenes, RAFT reagents, isocyanates, variety of ligands,  heteroaryl, biaryl, triaryl compounds, process impurities and metabolites.

Sreeni Labs is Looking for any potential opportunities where people need development of cost effective scalable routes followed by quick scale up to produce quality products in the pharmaceutical & specialty chemicals area. They can also take up custom synthesis and scale up of medchem analogues and building blocks.  They have flexible business model that will be in sink with customers. One can test their abilities & capabilities by giving couple of PO based (fee for service) projects.

Some of the compounds prepared by Sreeni labs;

str1str1

str1str1

str1str1

str1str1

str1str1

str1str1

 

 

 

See presentation below

LINK ON SLIDESHARE

Managing Director at Sreeni Labs Private Limited

 

Few Case Studies : Source SEEENI LABS

QUOTE………….

One virtual biotech company customer from USA, through a common friend approached Sreeni Labs and told that they are buying a tetrapeptide from Bachem on mg scale at a very high price and requested us to see if we can make 5g. We accepted the challenge and developed solution phase chemistry and delivered 6g and also the process procedures in 10 weeks time. The customer told that they are using same procedures with very minor modifications and produced the tetrapeptide ip to 100kg scale as the molecule is in Phase III.

 

One East coast customer in our first meeting told that they are working with 4 CROs of which two are in India and two are in China and politely asked why they should work with Sreeni Labs. We told that give us a project where your CROs failed to deliver and we will give a quote and work on it. You pay us only if we deliver and you satisfy with the data. They immediately gave us a project to make 1.5g and we delivered 2g product in 9 weeks. After receiving product and the data, the customer was extremely happy as their previous CRO couldn’t deliver even a milligram in four months with 3 FTEs.

 

One Midwest biotech company was struggling to remove palladium from final API as they were doing a Suzuki coupling with a very expensive aryl pinacol borane and bromo pyridine derivative with an expensive ligand and relatively large amount of palldium acetate. The cost of final step catalyst, ligand and the palladium scavenging resin were making the project not viable even though the product is generating excellent data in the clinic. At this point we signed an FTE agreement with them and in four months time, we were able to design and develop a non suzuki route based on acid base chemistry and made 15g of API and compared the analytical data and purity with the Suzuki route API. This solved all three problems and the customer was very pleased with the outcome.

 

One big pharma customer from east coast, wrote a structure of chemical intermediate on a paper napkin in our first meeting and asked us to see if we can make it. We told that we can make it and in less than 3 weeks time we made a gram sample and shared the analytical data. The customer was very pleased and asked us to make 500g. We delivered in 4 weeks and in the next three months we supplied 25kg of the same product.

 

Through a common friend reference, a European customer from a an academic institute, sent us an email requesting us to quote for 20mg of a compound with compound number mentioned in J. med. chem. paper. It is a polycyclic compound with four contiguous stereogenic centers.  We gave a quote and delivered 35 mg of product with full analytical data which was more pure than the published in literature. Later on we made 8g and 6g of the same product.

 

One West coast customer approached us through a common friend’s reference and told that they need to improve the chemistry of an advanced intermediate for their next campaign. At that time they are planning to make 15kg of that intermediate and purchased 50kg of starting raw material for $250,000. They also put five FTEs at a CRO  for 5 months to optimize the remaining 5 steps wherein they are using LAH, Sodium azide,  palladium catalyst and a column chromatography. We requested the customer not to purchase the 50kg raw material, and offered that we will make the 15kg for the price of raw material through a new route  in less than three months time. You pay us only after we deliver 15 kg material. The customer didn’t want to take a chance with their timeline as they didn’t work with us before but requested us to develop the chemistry. In 7 weeks time, we developed a very simple four step route for their advanced intermediate and made 50g. We used very inexpensive and readily available starting material. Our route gave three solid intermediates and completely eliminated chromatographic purifications.

 

One of my former colleague introduced an academic group in midwest and brought us a medchem project requiring synthesis of 65 challenging polyene compounds on 100mg scale. We designed synthetic routes and successfully prepared 60 compounds in a 15 month time.  

UNQUOTE…………

 

The man behind Seeni labs is Dr.Sreenivasa  Reddy Mundla

Sreenivasa Reddy

Dr. Sreenivasa Reddy Mundla

Managing Director at Sreeni Labs Private Limited

Sreeni Labs Private Limited

Road No:12, Plot No:24,25,26

  • IDA, Nacharam
    Hyderabad, 500076
    Telangana State, India

Links

LINKEDIN https://in.linkedin.com/in/sreenivasa-reddy-10b5876

FACEBOOK https://www.facebook.com/sreenivasa.mundla

RESEARCHGATE https://www.researchgate.net/profile/Sreenivasa_Mundla/info

EMAIL mundlasr@hotmail.com,  Info@sreenilabs.com, Sreeni@sreenilabs.com

Dr. Sreenivasa Mundla Reddy

Dr. M. Sreenivasa Reddy obtained Ph.D from University of Hyderabad under the direction Prof Professor Goverdhan Mehta in 1992. From 1992-1994, he was a post doctoral fellow at University of Wisconsin in Professor Jame Cook’s lab. From 1994 to 2000,  worked at Chemical process R&D at Procter & Gamble Pharmaceuticals (P&G). From 2001 to 2007 worked at Global Chemical Process R&D at Eli Lilly and Company in Indianapolis. 

In 2007  resigned to his  job and founded Sreeni Labs based in Hyderabad, Telangana, India  and started working with various global customers and solving various challenging synthesis problems. 
The main strength of Sreeni Labs is in the design, development of a novel chemical route and its development into a robust process followed by production of quality product from 100 grams to 100’s of kg scale.
 

They have helped number of customers by successfully developing highly economical simple chemistry routes to number of products that were made by Suzuki coupling. they are able to shorten the route by drastically reducing number of steps, avoiding use of palladium & expensive ligands. they always use readily available or easy to prepare starting materials in their design of synthetic routes.

Sreeni Labs is Looking for any potential opportunities where people need development of cost effective scalable routes followed by quick scale up to produce quality products in the pharmaceutical & specialty chemicals area. They have flexible business model that will be in sink with customers. One can test their abilities & capabilities by giving PO based projects

Experience

Founder & Managing Director

Sreeni Labs Private Limited

August 2007 – Present (8 years 11 months)

Sreeni Labs Profile

Sreeni Labs Profile

View On SlideShare

Principal Research Scientist

Eli Lilly and Company

March 2001 – August 2007 (6 years 6 months)

Senior Research Scientist

Procter & Gamble

July 1994 – February 2001 (6 years 8 months)

Education

University of Hyderabad

Doctor of Philosophy (Ph.D.), 
1986 – 1992

 

PUBLICATIONS

Article: Expansion of First-in-Class Drug Candidates That Sequester Toxic All-Trans-Retinal and Prevent Light-Induced Retinal Degeneration

Jianye Zhang · Zhiqian Dong · Sreenivasa Reddy Mundla · X Eric Hu · William Seibel ·Ruben Papoian · Krzysztof Palczewski · Marcin Golczak

Article: ChemInform Abstract: Regioselective Synthesis of 4Halo ortho-Dinitrobenzene Derivative

Sreenivasa Mundla

Aug 2010 · ChemInform

Article: Optimization of a Dihydropyrrolopyrazole Series of Transforming Growth Factor-β Type I Receptor Kinase Domain Inhibitors: Discovery of an Orally Bioavailable Transforming Growth Factor-β Receptor Type I Inhibitor as Antitumor Agent

Hong-yu Li · William T. McMillen · Charles R. Heap · Denis J. McCann · Lei Yan · Robert M. Campbell · Sreenivasa R. Mundla · Chi-Hsin R. King · Elizabeth A. Dierks · Bryan D. Anderson · Karen S. Britt · Karen L. Huss

Apr 2008 · Journal of Medicinal Chemistry

Article: ChemInform Abstract: A Concise Synthesis of Quinazolinone TGF-β RI Inhibitor Through One-Pot Three-Component Suzuki—Miyaura/Etherification and Imidate—Amide Rearrangement Reactions

Hong-yu Li · Yan Wang · William T. McMillen · Arindam Chatterjee · John E. Toth ·Sreenivasa R. Mundla · Matthew Voss · Robert D. Boyer · J. Scott Sawyer

Feb 2008 · ChemInform

Article: ChemInform Abstract: A Concise Synthesis of Quinazolinone TGF-β RI Inhibitor Through One-Pot Three-Component Suzuki—Miyaura/Etherification and Imidate—Amide Rearrangement Reactions

Hong-yu Li · Yan Wang · William T. McMillen · Arindam Chatterjee · John E. Toth ·Sreenivasa R. Mundla · Matthew Voss · Robert D. Boyer · J. Scott Sawyer

Nov 2007 · Tetrahedron

Article: Dihydropyrrolopyrazole Transforming Growth Factor-β Type I Receptor Kinase Domain Inhibitors: A Novel Benzimidazole Series with Selectivity versus Transforming Growth Factor-β Type II Receptor Kinase and Mixed Lineage Kinase-7

Hong-yu Li · Yan Wang · Charles R Heap · Chi-Hsin R King · Sreenivasa R Mundla · Matthew Voss · David K Clawson · Lei Yan · Robert M Campbell · Bryan D Anderson · Jill R Wagner ·Karen Britt · Ku X Lu · William T McMillen · Jonathan M Yingling

Apr 2006 · Journal of Medicinal Chemistry

Read full-textSource

Article: Studies on the Rh and Ir mediated tandem Pauson–Khand reaction. A new entry into the dicyclopenta[ a, d]cyclooctene ring system

Hui Cao · Sreenivasa R. Mundla · James M. Cook

Aug 2003 · Tetrahedron Letters

Article: ChemInform Abstract: A New Method for the Synthesis of 2,6-Dinitro and 2Halo6-nitrostyrenes

Sreenivasa R. Mundla

Nov 2000 · ChemInform

Article: ChemInform Abstract: A Novel Method for the Efficient Synthesis of 2-Arylamino-2-imidazolines

Read at

[LINK]

Patents by Inventor Dr. Sreenivasa Reddy Mundla

  • Patent number: 7872020

    Abstract: The present invention provides crystalline 2-(6-methyl-pyridin-2-yl)-3-[6-amido-quinolin-4-yl)-5,6-dihydro -4H-pyrrolo[1,2-b]pyrazole monohydrate.

    Type: Grant

    Filed: June 29, 2006

    Date of Patent: January 18, 2011

    Assignee: Eli Lilly and Company

    Inventor: Sreenivasa Reddy Mundla

  • Publication number: 20100120854

    Abstract: The present invention provides crystalline 2-(6-methyl-pyridin-2-yl)-3-[6-amido-quinolin-4-yl)-5,6-dihydro-4H-pyrrolo[1,2-b]pyrazole monohydrate.

    Type: Application

    Filed: June 29, 2006

    Publication date: May 13, 2010

    Applicant: ELI LILLY AND COMPANY

    Inventor: Sreenivasa Reddy Mundla

  • Patent number: 6066740

    Abstract: The present invention provides a process for making 2-amino-2-imidazoline, guanidine, and 2-amino-3,4,5,6-tetrahydroyrimidine derivatives by preparing the corresponding activated 2-thio-subsituted-2-derivative in a two-step, one-pot procedure and by further reacting yields this isolated derivative with the appropriate amine or its salts in the presence of a proton source. The present process allows for the preparation of 2-amino-2-imidazolines, quanidines, and 2-amino-3,4,5,6-tetrahydropyrimidines under reaction conditions that eliminate the need for lengthy, costly, or multiple low yielding steps, and highly toxic reactants. This process allows for improved yields and product purity and provides additional synthetic flexibility.

    Type: Grant

    Filed: November 25, 1997

    Date of Patent: May 23, 2000

    Assignee: The Procter & Gamble Company

    Inventors: Michael Selden Godlewski, Sean Rees Klopfenstein, Sreenivasa Reddy Mundla, William Lee Seibel, Randy Stuart Muth

TGF-β inhibitors

US 7872020 B2

Sreenivasa Reddy Mundla

The present invention provides 2-(6-methyl-pyridin-2-yl)-3-[6-amido-quinolin-4-yl) -5,6-dihydro-4H-pyrrolo[1,2-b]pyrazole monohydrate, i.e., Formula I.

Figure US07872020-20110118-C00002

EXAMPLE 1 Preparation of 2-(6-methyl-pyridin-2-yl)-3-[6-amido-quinolin-4-yl-5,6-dihydro-4H -pyrrolo[1,2-b]pyrazole monohydrate

Figure US07872020-20110118-C00008

Galunisertib

1H NMR (CDCl3): δ=9.0 ppm (d, 4.4 Hz, 1H); 8.23-8.19 ppm (m, 2H); 8.315 ppm (dd, 1.9 Hz, 8.9 Hz, 1H); 7.455 ppm (d, 4.4 Hz, 1H); 7.364 ppm (t, 7.7 Hz, 1H); 7.086 ppm (d, 8.0 Hz, 1H); 6.969 ppm (d, 7.7 Hz, 1H); 6.022 ppm (m, 1H); 5.497 ppm (m, 1H); 4.419 ppm (t, 7.3 Hz, 2H); 2.999 ppm (m, 2H); 2.770 ppm (p, 7.2 Hz, 7.4 Hz, 2H); 2.306 ppm (s, 3H); 1.817 ppm (m, 2H). MS ES+: 370.2; Exact: 369.16

ABOVE MOLECULE IS

https://newdrugapprovals.org/2016/05/04/galunisertib/

Galunisertib

Phase III

LY-2157299

CAS No.700874-72-2

 

 

READ MY PRESENTATION ON

Accelerating Generic Approvals, see how you can accelerate your drug development programme

Accelerating Generic Approvals by Dr Anthony Crasto

KEYWORDS   Sreenivasa Mundla Reddy, Managing Director, Sreeni Labs Private Limited, Hyderabad, Telangana, India,  new, economical, scalable routes, early clinical drug development stages, Custom synthesis, custom manufacturing, drug discovery, PHASE 1, PHASE 2, PHASE 3,  API, drugs, medicines

Share

PIERRE FABRE CDMO Supercritical Fluids – A supercritical CO2 GMP Unit for Pharmaceutical Applications.

 companies, PROCESS  Comments Off on PIERRE FABRE CDMO Supercritical Fluids – A supercritical CO2 GMP Unit for Pharmaceutical Applications.
Jun 132016
 

Pierre Fabre's Supercritical CO2 GMP unit.

read all by clicking

http://www.pharmaceutical-technology.com/contractors/contract/supercritical-fluids/?WT.mc_id=WN_Comp

The article gives contact details of below person

Bernard FREISS

Head of Supercrical Fluids Department

Supercritical Fluid Division Manager

Pierre Fabre

 

 

Gaillac, france

Map of Gaillac France
Gaillac
Commune in France
Gaillac is a commune in the Tarn department in southern France. It had in 2013 a population of 14,334 inhabitants. Wikipedia

 

…….//////PIERRE FABRE CDMO,  Supercritical Fluids, supercritical CO2 GMP Unit,  Pharmaceutical Applications.

Share

Biocon’s Rosuvastatin Calcium tablets get EU approval to treat hyperlipidemia

 companies  Comments Off on Biocon’s Rosuvastatin Calcium tablets get EU approval to treat hyperlipidemia
Feb 172016
 

Biocon’s Rosuvastatin Calcium tablets get EU approval to treat hyperlipidemia
Indian biopharmaceutical company Biocon has received approval from the European Commission for its Rosuvastatin Calcium tablets to treat hyperlipidemia or mixed dyslipidemia.

http://www.pharmaceutical-technology.com/news/newsbiocons-rosuvastatin-calcium-tablets-gets-eu-approval-to-treat-hyperlipidemia-4811839?WT.mc_id=DN_News

Indian biopharmaceutical company Biocon has received approval from the European Commission for its Rosuvastatin Calcium tablets to treat hyperlipidemia or mixed dyslipidemia.

Hyperlipidemia is a common genetic disorder that increases lipids and/or lipoproteins levels in the blood.

The first generic formulation approval will allow Biocon to sell Rosuvastatin Calcium 5mg, 10mg, 20mg and 40mg tablets in more than 15 European countries, starting in fiscal 2017.

“This approval paves the way for Biocon to launch Rosuvastatin Calcium tablets in several European countries.”

The company plans to collaborate with regional partners to market the drug; a generic equivalent of Crestor tablets.

Biocon chairperson and managing director Kiran Mazumdar-Shaw said: “This is indeed a proud moment for Biocon’s Small Molecules business.

Biocon chairperson and managing director Kiran Mazumdar-Shaw

“This approval paves the way for Biocon to launch Rosuvastatin Calcium tablets in several European countries.”

The approval will allow the company to address the $1.2bn opportunity in the EU. It will also make it easier for the company to market its products in emerging markets, where regulatory clearances are primarily based on approvals given by regulators in the US / EU.

Biocon was the first generic company to receive a certificate of suitability (CEP) for Rosuvastatin Calcium API from the European Directorate for the Quality of Medicines (EDQM).

CEP certification indicates that an API is suitable for use in medicinal products in the EU.

Biocon CEO and joint managing director Dr Arun Chandavarkar said: “The European approval for Biocon’s generic version of Rosuvastatin Calcium underscores Biocon’s unique strengths in the chronic therapies space and our compliance with global standards that enable us to achieve the highest quality standards for all our products.

“It augurs well for this nascent business, which will be one of our growth drivers in the coming years.”

The company plans to boost its generic formulations business with a target of 20-25 filings over the next few years.

Additionally, Biocon is developing a new facility in Bengaluru, in the Indian state of Karnataka, where it will produce oral solid dosage formulations.

Biocon CEO and joint managing director Dr Arun Chandavarkar

/////////

Share

Which Pharmas Spend the Most on R&D?

 companies  Comments Off on Which Pharmas Spend the Most on R&D?
Dec 042014
 

Which Pharmas Spend the Most on R&D?

Pharmas and biotechs have spent $1 trillon on R&D over the last decade.

Share

Welcome Scientific update to Pune, India 2-3 and 4-5 Dec 2014 for celebrating Process chemistry

 companies, PROCESS  Comments Off on Welcome Scientific update to Pune, India 2-3 and 4-5 Dec 2014 for celebrating Process chemistry
Sep 292014
 

 

WEBSITE http://www.scientificupdate.co.uk/

SCIENTIFIC UPDATE HAS A REPUTATION FOR ITS HIGH QUALITY EVENTS, BOTH FOR THE SCIENTIFIC CONTENT AND ALSO FOR THE EFFICIENCY OF ITS ORGANISATION. KEEP YOUR SKILLS UP TO DATE AND INVEST IN YOUR CONTINUING PERSONAL PROFESSIONAL DEVELOPMENT.

http://makeinindia.com/

TRAINING COURSE   2-3 DEC 2014

Process Development for Low Cost Manufacturing

When:02.12.2014 – 03.12.2014

Tutors:

Where: National Chemical Laboratory – Pune, India

Brochure:View Brochure

Register http://scientificupdate.co.uk/training/scheduled-training-courses.html

 

DESCRIPTION

Chemical process research and development is recognised as a key function during the commercialisation of a new product particularly in the generic and contract manufacturing arms of the chemical, agrochemical and pharmaceutical industries.

The synthesis and individual processes must be economic, safe and must generate product that meets the necessary quality requirements.

This 2-day course presented by highly experienced process chemists will concentrate on the development and optimisation of efficient processes to target molecules with an emphasis on raw material cost, solvent choice, yield improvement, process efficiency and work up, and waste minimisation.

Process robustness testing and reaction optimisation via stastical methods will also be covered.

A discussion of patent issues and areas where engineering and technology can help reduce operating costs.

The use of engineering and technology solutions to reduce costs will be discussed and throughout the course the emphasis will be on minimising costs and maximising returns.

 

 

Conference 4-5 DEC 2014

TITLE . Organic Process Research & Development – India

Subtitle:The 32nd International Conference and Exhibition

When:04.12.2014 – 05.12.2014

Where:National Chemical Laboratory – Pune, India

Brochure:View Brochure

Register..http://scientificupdate.co.uk/conferences/conferences-and-workshops.html

Organic Process Research & Development - India

for

  • Process Research & Development Chemists
  • Chemical Engineers in Industry
  • Heads of Departments & Team Leaders

Benefits

  • Invest in yourself: keeping up to date on current developments and future trends could mean greater job security.
  • Learn from a wide range of industrial case studies given by hand-picked industrial speakers.
  • Take home relevant ideas and information that are directly applicable to your own work with the full proceedings and a CD of the talks.
  • Save time. Our intensive, commercial-free programme means less time away from work.
  • Meet and network with the key people in the industry in a relaxed and informal atmosphere.

Do you want to improve efficiency and innovation in your synthetic route design, development and optimisation?

The efficient conversion of a chemical process into a process for manufacture on tonnage scale has always been of importance in the chemical and pharmaceutical industries. However, in the current economic and regulatory climate, it has become increasingly vital and challenging to do so efficiently. Indeed, it has never been so important to keep up to date with the latest developments in this dynamic field.

At this Organic Process Research & Development Conference, you will hear detailed presentations and case studies from top international chemists. The hand-picked programme of speakers has been put together specifically for an industrial audience. They will discuss the latest issues relating to synthetic route design, development and optimisation in the pharmaceutical, fine chemical and allied fields.  Unlike other conferences, practically all our speakers are experts from industry, which means the ideas and information you take home will be directly applicable to your own work.

The smaller numbers at our conferences create a more intimate atmosphere. You will enjoy plenty of opportunities to meet and network with speakers and fellow attendees during the reception, sit-down lunches and extended coffee breaks in a relaxed and informal environment. Together, you can explore the different strategies and tactics evolving to meet today’s challenges.

This is held in Pune, close proximity to Mumbai city, very convenient to stay and travel to either in Pune or Mumbai. I feel this should be an opportunity to be grabbed before the conference is full and having no room

Hurry up rush

References

http://newdrugapprovals.org/scientificupdate-uk-on-a-roll/

http://scientificupdate.co.uk/conferences/conferences-and-workshops.html

http://en.wikipedia.org/wiki/Pune

PROFILES

Will Watson

Will Watson

Dr Will Watson gained his PhD in Organic Chemistry from the University of Leeds in 1980. He joined the BP Research Centre at Sunbury-on-Thames and spent five and a half years working as a research chemist on a variety of topics including catalytic dewaxing, residue upgrading, synthesis of novel oxygenates for use as gasoline supplements, surfactants for use as gasoline detergent additives and non-linear optical compounds.

In 1986 he joined Lancaster Synthesis and during the next 7 years he was responsible for laboratory scale production and process research and development to support Lancaster’s catalogue, semi-bulk and custom synthesis businesses.

In 1993 he was appointed to the position of Technical Director, responsible for all Production (Laboratory and Pilot Plant scale), Process Research and Development, Engineering and Quality Control. He helped set up and run the Lancaster Laboratories near Chennai, India and had technical responsibility for the former PCR laboratories at Gainesville, Florida.

He joined Scientific Update as Technical Director in May 2000. He has revised and rewritten the ‘Chemical Development and Scale Up in the Fine Chemical & Pharmaceutical Industries’ course and gives this course regularly around the world. He has been instrumental in setting up and developing new courses such as ‘Interfacing Chemistry with Patents’ and ‘Making and Using Fluoroorganic Molecules’.

He is also involved in an advisory capacity in setting up conferences and in the running of the events. He is active in the consultancy side of the business and sits on the Scientific Advisory Boards of various companies.

………………………………………………………………………………………………….

John Knight

John Knight

Dr John Knight gained a first class honours degree in chemistry at the University of Southampton, UK. John remained at Southampton to study for his PhD in synthetic methodology utilizing radical cyclisation and dipolar cyloaddition chemistry.

After gaining his PhD, John moved to Columbia University, New York, USA where he worked as a NATO Postdoctoral Fellow with Professor Gilbert Stork. John returned to the UK in 1987 joining Glaxo Group Research (now GSK) as a medicinal chemist, where he remained for 4 years before moving to the process research and development department at Glaxo, where he remained for a further 3½ years.

During his time at Glaxo, John worked on a number of projects and gained considerable plant experience (pilot and manufacturing). In 1994 John moved to Oxford Asymmetry (later changing its name to Evotec and most recently to Aptuit) when it had just 25 staff. John’s major role when first at Oxford Asymmetry was to work with a consultant project manager to design, build and commission a small pilot plant, whilst in parallel developing the chemistry PRD effort at Oxford Asymmetry.

The plant was fully operational within 18 months, operating to a 24h/7d shift pattern. John continued to run the pilot plant for a further 3 years, during which time he had considerable input into the design of a second plant, which was completed and commissioned in 2000. After an 18-month period at a small pharmaceutical company, John returned to Oxford in 2000 (by now called Evotec) to head the PRD department. John remained in this position for 6.5 years, during which time he assisted in its expansion, established a team to perform polymorph and salt screening studies and established and maintained high standards of development expertise across the department.

John has managed the chemical development and transfer of numerous NCE’s into the plant for clients and been involved in process validations. He joined Scientific Update in January 2008 as Scientific Director.

Pune images

From top: Fergusson College, Mahatma Gandhi Road (left), Shaniwarwada (right), the HSBC Global Technology India Headquarters, and the National War Memorial Southern Command
From top:1 Fergusson College, 2 Mahatma Gandhi RoadShaniwarwada 3 the HSBC Global Technology India Headquarters, and the 4National War Memorial Southern Command

 

NCL PUNE

The National Chemical Laboratory is located in the state of Maharashtra in India. Maharashtra state is the largest contributor to India’s GDP. The National Chemical Laboratory is located in Pune city, and is the cultural capital of Maharashtra. Pune city is second only to Mumbai (the business capital of India) in size and industrial strength. Pune points of interest include: The tourist places in Pune include: Lal Deval Synagogue, Bund Garden, Osho Ashram, Shindyanchi Chhatri and Pataleshwar Cave Temple.

http://makeinindia.com/

MAKE IN INDIA

http://makeinindia.com/

http://makeinindia.com/sector/pharmaceuticals/

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

 

 

 

KEYWORDS

JOHN KNIGHT, WILL WATSON,  SCIENTIFIC UPDATE, PROCESS, COURSE, CONFERENCE, INDIA, PUNE, PROCESS DEVELOPMENT, LOW COST,  MANUFACTURING, SCALEUP

Share
Follow

Get every new post on this blog delivered to your Inbox.

Join other followers: