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.
Amgen announced the FDA has approved RIABNI, a biosimilar to Rituxan.
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Wednesday, April 16, 2014
Patheon , the pharmaceutical services business owned by DPx Holdings, recently received FDA approval for its Bourgoin, France site to begin manufacturing and selling drugs to the U.S. market. The Bourgoin site specializes in development and ...
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JanOne has received confirmation from the FDA for the IND sponsorship transfer covering its sodium nitrite tablets previously held by Soin Neuroscience.
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In response to scammers on the internet selling unproven medical products, the FDA has taken a number of steps to find and stop those selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19.
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The FDA finalized guidance for industry, “Competitive Generic Therapies,” which describes the process that generic drug applicants should follow to request designation of a drug as a CGT and the criteria for that designation.
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Glenmark has received a CRL from the FDA for Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray.
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Wednesday, September 04, 2019
The FDA has issued a Complete Response Letter for the New Drug Application for Insulin Glargine filed by the company’s partner, Mylan.
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Tuesday, January 26, 2021
The FDA has issued a guidance to notify drug manufacturers, including repackers, relabelers, alcohol suppliers and compounders, of FDA’s policy on testing of alcohol or isopropyl alcohol for methanol prior to using the ingredient in drugs.
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Wednesday, January 29, 2020
The FDA has issued a warning letter to Sunstar Guangzhou following the inspection of the company’s drug manufacturing facility.
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The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately six months.
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As previously disclosed, Albany Molecular Research, Inc. received a warning letter, dated August 17, 2010, from the U.S. Food and Drug Administration (FDA) in connection with the FDA’s inspection of the Company’s pharmaceutical manufacturing ...
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The FDA has been determining the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March.
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Wednesday, August 05, 2020
The FDA proposed to include four bulk drug substances on the list of bulk drug substances that outsourcing facilities may use in drug compounding consistent with section 503B of the Federal Food, Drug & Cosmetic Act.
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Wednesday, September 12, 2018
The FDA has announced the availability of a draft guidance for industry that is applicable to holders of approved new drug applications, ANDAs, new animal drug applications, abbreviated new animal drug applications and holders of drug master files ...
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The FDA has proposed to include one additional bulk drug substance on the list of bulk drug substances that outsourcing facilities may use in drug compounding consistent with section 503B of the Federal Food, Drug and Cosmetic Act.
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