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Caplin Point’s arm gets USFDA’s nod for Methylprednisolone Acetate Injectable Suspension

27 Jan 2026 Evaluate

Caplin Point Laboratories’ subsidiary -- Caplin Steriles (Caplin) has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Methylprednisolone Acetate Injectable Suspension USP, 40mg/mL & 80mg/mL Single Dose vials, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DEPO-MEDROL from Pfizer Inc., USA.

Methylprednisolone Acetate Injectable Suspension is primarily used as an anti-inflammatory treatment in various conditions, including in allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic diseases, ophthalmic diseases, respiratory diseases, rheumatic disorders etc. 

Caplin Point Laboratories is the mid-sized company in India’s pharmaceutical sector to be engaged in the manufacture of APIs, finished formulations, research & development, clinical research, frontend generic presence in Latin America, brand marketing in Francophone Africa and an USFDA approved injectable facility.

Peers
Company Name CMP
Sun Pharma. Inds. 1853.00
Dr. Reddys Labs. 1200.40
Cipla 1404.00
Lupin 2098.00
Zydus Lifesciences 1180.00
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