- Indian drugmaker Ipca Laboratories Ltd. announced Wednesday it would buy North Carolina-based Pisgah Labs Inc., putting down $9.65 million to acquire 100% of the U.S. company's shares.
- Pisgah Labs, founded in 1981, is a CDMO that specializes in the production of active pharmaceutical ingredients (APIs) and intermediates — a small but growing part of Ipca's business.
- For Ipca, Pisgah will serve as a manufacturing base in the U.S. and help complement the drugmaker's small volume API production.
Like other Indian drug manufacturers, Ipca has been hit with regulatory difficulties by the Food and Drug Administration's stepped-up oversight of foreign production sites.
Three of the company's manufacturing facilities are currently listed on an FDA import alert list that permits detention without inspection of imports produced at those sites. An annual report from Ipca noted the FDA's actions had hurt its US formulations and API business.
Buying Pisgah Lab and its facility in North Carolina doesn't evade the FDA's regulatory gaze, but it could give Ipca more flexibility and a production foothold in a key market.
Pisgah will continue to operate under its corporate name, operating out of North Carolina as before. In the financial year ending last April 30, Pisgah pulled in earnings before interest, depreciation and taxes of $1.14 million on total income of $2.89 million — a relatively small addition to Ipca's overall API and formulations business.