Strides Pharma Acquires U.S. FDA Approved Manufacturing Plant in Florida
Strides Pharma Science Ltd. on Tuesday said its step down subsidiary Strides Pharma Inc. has acquired a manufacturing facility in Florida from Micelle BioPharma Inc.
The Florida plant already has the approval of U.S. Food and Drug Administration. Strides Pharma now has eight formulation sites globally catering to regulated and emerging markets.
"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 crore) and will invest up to $10 million (Rs 71.85 crore) to build incremental capabilities and add additional dosage formats," Strides Pharma Science said in an exchange filing.
The site has undergone several successful U.S. FDA inspections and has no outstanding observations, the exchange filing added.
"Micelle's facility is based in Riviera Beach, Florida, and is one of the very few manufacturing facilities in the U.S. with a soft gel capsule manufacturing suite for formulations with containment needs. It is also the only U.S. FDA approved integrated manufacturing-packaging SGC facility in the U.S."
Elaborating on the strategic rationale for the acquisition, Strides Pharma Science said its U.S. business has seen a significant ramp-up over the last few quarters, driven by sustained business growth in base products and new launches through its own front-end.
SGC is one of the important pivots in the company's growth. Strides Pharma has a portfolio of over 10 approved SGCs in the U.S. and other regulated markets and a pipeline of 15 SGC Abbreviated New Drug Applications filed/under filing for the U.S.
Strides Pharma Science 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, it added.