USFDA27 Jan 2026, 03:35 pm
Caplin Point's Subsidiary, Caplin Steriles, Receives Final USFDA Approval for Methylprednisolone Acetate Injectable Suspension
AI Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the USFDA for its ANDA Methylprednisolone Acetate Injectable Suspension USP, 40mg/mL & 80mg/mL Single Dose vials. This generic therapeutic equivalent version of the RLD DEPO-MEDROL from Pfizer Inc., USA, is primarily used as an anti-inflammatory treatment in various conditions. According to IQVIA™, the product had US sales of approximately $57.4 million for the 12-month period ending November 2025.
Key Highlights
- Caplin Steriles Limited receives final approval from the USFDA for Methylprednisolone Acetate Injectable Suspension USP
- The product is a generic therapeutic equivalent version of the RLD DEPO-MEDROL from Pfizer Inc., USA
- The product is primarily used as an anti-inflammatory treatment in various conditions
- According to IQVIA™, the product had US sales of approximately $57.4 million for the 12-month period ending November 2025
- Caplin Point Laboratories Limited is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa