Caplin Point secures two USFDA approvals, INVIMA clearance

Caplin Point Laboratories Limited announced significant regulatory milestones this week, starting with a USFDA final approval for its subsidiary Caplin Steriles Limited's Abbreviated New Drug Application (ANDA) for Acetaminophen Injection, 1000 mg/100 mL (10 mg/mL) Single-dose Infusion Bags. This generic equivalent of Mallinckrodt Pharmaceuticals Ireland Limited's RLD targets a market with US sales of approximately $86 million for the 12 months ending October 2025.

Following this, Caplin Steriles received another USFDA final approval for its ANDA for Linezolid Injection, 600 mg/300 mL (2 mg/mL) Single-dose Infusion Bags, a generic equivalent of Pfizer Inc.'s ZYVOX. This product addresses a market with US sales of approximately $23 million for the 12 months ending October 2025. With these, Caplin Steriles now has 44 ANDA approvals out of 53 filed.

Further bolstering its global presence, Caplin Point Laboratories successfully completed an INVIMA – Colombia inspection at its Puducherry injectables facility between December 8th and 12th, 2025. This reinforces the company's commitment to Latin American expansion and high-quality medicine delivery.