A roundup of developments and latest news from India (Aurobindo, Biocon) and the US (Cosette Pharmaceuticals).

India

FDA Issues Form 483 to Aurobindo API Mfg Facilities in India

The US Food and Drug Administration (FDA) has issued a Form 483 following Aurobindo’s active pharmaceutical ingredient (API) manufacturing facilities in Pashamylaram, Hyderabad, India and Gaddapotharam, Hyderabad, India. Four observations were issued at each facility following inspections from October 21 to October 28, 2019 and October 21 to October 25, 2019, respectively at the Pashamylaram and Gaddapotharam facilities.

The facilities were Unit V, API manufacturing facility, and Unit VIII API manufacturing facility. Aurobindo says it believes these observations are related to procedural improvements and that none of the observations are related to data integrity.

Aurobindo says for Unit IV, its formulation manufacturing facility at Pashamylaram, Hyderabad, India, the inspection is still in progress.

Source: Aurobindo 

FDA Issues Establishment Inspection Report to Biocon Biologics Facility

Biocon, a Bangalore, India-based biopharmaceutical company, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its biologics drug- product facility in Bangalore (i.e.,Bengaluru, India), stating the inspection is closed.

Biocon had undergone a routine surveillance cGMP inspection of this drug-product manufacturing facility from August 22 to August 30, 2019. Biocon says the receipt of an EIR indicates a successful closure of this inspection. The FDA says an EIR is provided to the inspected establishment once the FDA determines an inspection is closed.

In October 2019, the FDA approved Biocon’s new drug-product filling line for a biosimilar of Roche’s Herception (trastuzumab) 150 mg vials its biologics facility in Bangalore, following a pre-approval inspection of the facility in September 2019.

Source: Biocon

United States

Cosette Buys G&W Laboratories’ Finished Dosage Mfg Plant in North Carolina

Cosette Pharmaceuticals, a New Jersey-based generics pharmaceutical company primarily focused on extended topical and suppository products, has agreed to acquire a finished dosage manufacturing plant in LinconInton, North Carolina from G&W Laboratories and Avista Capital Partners, a private-equity firm.

Cosette Pharmaceuticals is a generic pharmaceutical company specializing in the areas of dermatology and allergy, with products available in dosage forms such as creams, ointments, lotions, solutions, gels, pastes and suppositories. The company was formed when Avista Capital Partners purchased the extended topicals and dermatology portfolio of G&W Laboratories in December 2018. 

The transaction does not involve G&W Labs’ other businesses, including investments to drive efficiency in the pharmaceutical value chain and contract manufacturing operations in Sellersville, Pennsylvania and Lincolnton, North Carolina.

Source: Cosette Pharmaceuticals