Caplin Point Laboratories announces its subsidiary, Caplin Steriles Limited, has received final approval from the USFDA for Methylprednisolone Acetate Injectable Suspension USP. This approval covers 40mg/mL & 80mg/mL single-dose vials, a generic version of Pfizer’s DEPO-MEDROL. The product addresses anti-inflammatory needs. US sales for this suspension were approximately $57.4 million for the 12 months ending November 2025.
USFDA Approval for Injectable Suspension
Caplin Point Laboratories’ subsidiary, Caplin Steriles Limited, has secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) concerning Methylprednisolone Acetate Injectable Suspension USP.
Product Details
The approved product includes 40mg/mL and 80mg/mL single-dose vials. It is identified as a generic therapeutic equivalent of the Reference Listed Drug (RLD) DEPO-MEDROL, originally from Pfizer Inc., USA.
Therapeutic Use
Methylprednisolone Acetate Injectable Suspension is primarily used as an anti-inflammatory treatment for various conditions, including allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic diseases, ophthalmic diseases, respiratory diseases, and rheumatic disorders.
Market Overview
According to IQVIA™ (IMS Health) data, Methylprednisolone Acetate Injectable Suspension USP, 40mg/mL & 80mg/mL Single Dose vials, had US sales of approximately $57.4 million for the 12-month period ending November 2025. This highlights the existing market demand and potential for Caplin Steriles’ newly approved product.
Caplin Steriles’ Capabilities
Caplin Steriles Limited (CSL) has developed and filed 53 ANDAs in the USA on its own and with partners, with 50 approvals (including acquired ANDA’s) so far. CSL is also working on a portfolio of 55+ simple and complex Injectable and Ophthalmic products.
Source: BSE
