Pharmaceutical Technology Editors

FDA found no observations during recent inspection of Regis Technologies manufacturing site.

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

The agreement comprises technology transfer and commercial manufacturing of Tillotts’ gastroenterology products.

Sandoz won FDA approval for its biosimilar version of Enbrel.

Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

Researchers at the Massachusetts Eye and Ear Infirmary developed a potential drug delivery method using a contact lens to deliver glaucoma medication.

The company is voluntarily recalling one lot of product due to a potential packaging mistake.

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.

FDA issued a warning letter to College Pharmacy for multiple violations.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.

The company will launch a generic version of EpiPen at the price of $300 for a two-pack.

FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

The company will be investing $3.5 million in a 15,00-square-foot facility in Greenville, North Carolina.

CPhI Worldwide’s Pre-Connect Congress will discuss current trends in the pharmaceutical industry.

The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.

Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.

ACG APL is the first Asian company to receive this certification.

The portfolio in this agreement include approved antibiotics Merrem, Zinforo, and Zavicefta, as well as candidates in clinical development, ATM-AVI and CXL.

AMRI entered into a non-exclusive license agreement with the Broad Institute for the use of CRISPR-Cas9 gene-editing technology.

A recent paper outlines a methodology to help development teams decide whether switching from batch to continuous mode makes financial and technical sense.

Pfizer will acquire Medivation for approximately $14 billion.

The joint venture, created through a collaboration with Bayer and CRISPR Therapeutics, will be based in Cambridge, MA.

The company is opening two offices in the United States that will offer serialization, automation, and process control services.

The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.

CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility.

Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.

Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.

TOPAS Advanced Polymers announces its COC materials are compliant with new USP standard for pharma plastic packaging systems.