Small Molecule API Manufacturing


PharmSource has identified almost 300 contract manufacturers that can make API small molecule products. In total, these companies have operations in over 40 different countries around the world. We maintain details for most of these on their project acceptance criteria, processing capabilities and production scales, specialty chemistry services, finishing processes, regulatory approvals and other information.

Here’s a quick summary of some recent activities in the API small molecule market during Q4 2014 (alpha order by company):

Company HQ Activity
BASF Pharma Ingredients and Services USA Will sell its omega-3 manufacturing facility in Norway
Biocon India Bought back stake in research services subsidiary Syngene International
Cadila Pharmaceuticals India Received FDA warning letter on API manufacturing site in Gujarat, India
Catalent USA Acquired Micron Technologies; to provide solubility-enhancing solutions for current generation of small molecule medicines
DPx Fine Chemicals USA Closing Venlo manufacturing facility
Dr. Reddy’s India Received Form 483 at FDA inspection
Johnson Matthey UK Purchased manufacturing facility in Scotland for APIs and intermediates
Laurus Labs India Added Varicol continuous chromatography system
Lonza Switzerland Offers licensing options for chemical microreaction technology
MRIGlobal USA Won $3 million contract amendment from NCI for HPV vaccine for Phase I trial
Novaset France Sold it Bahamian manufacturing facility and subsidiary Pharmachem Technologies
Signa/ACIC Mexico Received FDA approval for Esbriet
WuXi PharmaTech China Plans $100 million small molecule API facility

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Jim Miller is the founder and president of PharmSource Information Services, Inc. A preeminent expert in bio/pharmaceutical outsourcing, Jim established and presides over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing, PharmSource STRATEGIC ADVANTAGE. He is editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report.

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