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.
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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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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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, 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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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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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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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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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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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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Amgen announced the FDA has approved RIABNI, a biosimilar to Rituxan.
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Thursday, August 16, 2018
Grifols has received approval from the FDA to relocate existing immunodiagnostic manufacturing operations to a new Consolidated Manufacturing Facility in Emeryville, California.
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Tuesday, October 06, 2020
Ajinomoto Bio-Pharma Services announced the FDA has approved the first commercial drug manufactured using the company's AJIPHASE production process.
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Wednesday, April 13, 2022
Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Biofrontera Pharma’s cGMP laboratory in Leverkusen, Germany, as a contract laboratory for batch control and stability testing of Ameluz® (aminolevulinic acid ...
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Patients expect and deserve high-quality drugs – this means consistently safe and effective medicines, free of defects and contamination.
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The FDA has announced the retirement of the MedWatch to Manufacturer Program.
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