Pharmaceutical Outsourcing covers news of importance to the contract services segment of the pharmaceutical industry.
Collected from the most trusted on-line resources, these news stories are chosen and published here based on their relevance to the pharmaceutical industry.
Topics of interest typically include: mergers and acquisitions, service additions, new capabilities, personnel changes, news from the FDA and other international regulatory and standard-setting agencies, and new outsourcing contracts and deals.
If you are looking to stay up-to-date with the news in your industry, this resource is vital for your industry knowledge.
Wednesday, September 25, 2019
Catalent and Minerva Neurosciences have entered into a commercial supply agreement for roluperidone, an investigational compound from Minerva, for symptoms of schizophrenia.
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Wednesday, September 25, 2019
The FDA has announced a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz used to decrease the amount of acid created by the stomach.
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Wednesday, September 25, 2019
Versatope Therapeutics has been awarded a contract with NIAID, a division of the National Institutes of Health (NIH), worth up to $17.9M over five years.
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Thursday, September 26, 2019
Torrent is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets to the consumer level.
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The FDA has awarded a cooperative agreement grant to the NABP to establish an information-sharing system for drug compounding activities that are primarily overseen by states.
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Tuesday, October 15, 2019
Innoveix Pharmaceuticals is voluntarily recalling all sterile compounded drug products, within expiry, to the consumer level
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Tuesday, October 15, 2019
The FDA has posted a warning letter to Torrent Pharmaceuticals in Ahmedabad, Gujarat, India.
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Wednesday, October 16, 2019
CorMedix has completed its interaction with the FDA related to the CMC package that will be needed to support Neutrolin’s NDA.
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Wednesday, October 23, 2019
The FDA has issued a warning letter to Jiangsu NHWA.
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Thursday, October 24, 2019
Vertex announced an access agreement with NHS England for all currently licensed Vertex cystic fibrosis medicines and any future indications of these medicines.
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Wednesday, October 30, 2019
The FDA issued a revised final guidance in January 2017, Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act, which is in place while the FDA develops the 503B...
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Wednesday, November 06, 2019
C2 PHARMA continues to build its active pharmaceutical ingredient (API) and botanical extracts product portfolio.
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Wednesday, November 06, 2019
Samsung Bioepis has entered into a new commercialization agreement with Biogen for two biosimilar candidates under development by Samsung Bioepis, SB11 (ranibizumab) and SB15 (aflibercept).
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Thursday, November 07, 2019
ANI Pharmaceuticals announced its partner Pii has received FDA approval of a Prior Approval Supplement for Bretylium Tosylate Injection.
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Friday, November 08, 2019
IDT Biologika announced the NIAID of the NIH has awarded the company a new Task Order within the 10-year IDIQ to provide process development activities and production of a vaccine against the RSV.
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