Strides Pharma acquires USFDA approved manufacturing facility in US

Strides Pharma Science has said that its step down subsidiary Strides Pharma Inc has acquired a US health regulator-approved manufacturing facility in Florida from Micelle BioPharma Inc. “Strides Pharma Inc has acquired the manufacturing facility under an asset purchase agreement with Micelle Biopharma Inc for a consideration of $0.5 million (Rs 3.59 crores) and will invest up to $10 million (Rs 71.85 crores) to build incremental capabilities and add additional dosage formats,” the company said in a regulatory filing.

Strides Pharma Science said the site has undergone several successful USFDA inspections and has no outstanding observations. “Micelle’s facility is based in Riviera Beach, Florida and is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs. It is also the only US Food and Drug Administration (USFDA) approved integrated manufacturing-packaging SGC facility in the US,” the company added.

Elaborating on the strategic rationale behind the acquisition, Strides Pharma Science said US business for Strides has seen a significant ramp up over the last few quarters driven by sustained business growth in base products and new product introductions through its own front-end.

SGC is one of the important pivots in the company’s growth. Strides has portfolio of over 10 approved SGCs in the US and other regulated markets and a pipeline of 15 SGC abbreviated new drug applications (ANDAs) filed/under filing for the US, the company said.

Strides Pharma Science said the company has over two billion annual capacity of SGC at its flagship site in Bengaluru. The Florida site will augment this capacity and will offer an alternate site to support the company’s growth plans.

The company also said that with the addition of the Florida site, Strides now has eight formulation sites globally catering to the regulated and emerging markets.