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On May 19, 2023, Krystal Biotech, a client of Berkshire Sterile Manufacturing (BSM), received FDA approval for VYJUVEK™, the first-ever topical gene therapy approved to treat dystrophic epidermolysis bullosa (DEB) in children and adults six months of age or older.

The Ritedose Corporation, the leading contract development and manufacturing organization specializing in sterile Blow Fill Seal production, announces a significant expansion of its production capabilities to meet the demand for ophthalmic and respiratory medications.

A historic transplant of a genetically modified pig heart has been successfully performed on a 20-year Navy veteran and married father of two suffering from end-stage cardiovascular disease.

Multiply Labs and Fedegari Group Collaborate to Add Sterilization to Automated Cell Therapy Manufacturing for Eliminating Contamination Risks.

Berkshire Sterile Manufacturing’s client, Fennec Pharmaceuticals Inc., received FDA approval of their drug product, PEDMARK – a sodium thiosulfate Injection with an indication to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors.

Last week, Eli Lilly also responded to the President’s tariff warnings by investing $27 billion to construct four manufacturing facilities across the U.S. in five years.

On March 1, 2022, a long-term client of Berkshire Sterile Manufacturing (BSM) announced the FDA approval of their Abbreviated New Drug Application (ANDA) for their generic apomorphine hydrochloride cartridges.

DifGen Pharmaceuticals LLC (“DifGen”) announced today that it has acquired KriGen LLC a fully integrated sterile drug product manufacturer with capability to manufacture a wide range of parenteral products including LVP bags PFS, Microspheres & complex Long Acting Injectables.