Shilpa Medicare’s arm gets marketing authorization permission for Adalimumab injection

30 Jun 2023 Evaluate

Shilpa Medicare’s wholly owned subsidiary -- Shilpa Biologicals (SBPL) has received the marketing authorization permission for its Adalimumab 40 mg/0.4mL injection in prefilled syringe (PFS), a biosimilar of adalimumab higher concentration formulation (100mg/mL) in India. This is used for the treatment of Rheumatoid Arthritis (moderate to severe active RA & severe active and progressive RA) for which the phase 3 clinical trial has been successfully completed in Q3 2022. This formulation will contribute to increased patient comfort based on reduced injection volume.  

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.

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