Medicamen Biotech Secures USFDA Approval for Bortezomib Injection, Strengthening Oncology Portfolio

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Medicamen Biotech Ltd. has successfully received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (USFDA) for Bortezomib for Injection 3.5 mg, marking a significant milestone in its oncology drug portfolio. The approval is expected to boost the company’s presence in the US generic pharmaceutical market, particularly in cancer treatment formulations.

USFDA Approval for Bortezomib Injection:

Medicamen Biotech has secured ANDA approval for Bortezomib for Injection 3.5 mg, a widely used chemotherapy drug for multiple myeloma and mantle cell lymphoma.
The approval allows Medicamen to manufacture and market the drug in the US, expanding its oncology product offerings.

Strategic Impact on Business Growth:

The company’s Research & Development team internally developed the Bortezomib Active Pharmaceutical Ingredient (API).
Shivalik Rasayan Ltd., Medicamen’s holding company, has filed the Drug Master File (DMF) for Bortezomib API with the USFDA, ensuring quality and regulatory compliance.

Market Reaction & Financial Performance:

Medicamen Biotech’s shares rose 5.12%, trading at ₹755.30, following the announcement.
The company reported a 20% year-on-year revenue increase, reaching ₹138 crore in FY23, despite a slight dip in operating profit margins.

Future Outlook & Expansion Plans:

The USFDA approval is expected to trigger an audit process, paving the way for commercial production and distribution.
Medicamen Biotech aims to expand its oncology drug portfolio, reinforcing its commitment to affordable cancer treatments.

Medicamen Biotech’s latest USFDA approval marks a major step in its global expansion, strengthening its position in the competitive oncology drug market.

Source: Medicamen Biotech Official News, The Hindu Business Line, and Market Updates.