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Shilpa Medicare Arm’s Karnataka Facility Clears GMP Inspection

Jul 12, 2024

By: BlinkX Research Team

Shilpa Medicare announced on Tuesday, July 9, that ANVISA-Brazil had successfully completed a good manufacturing practice (GMP) inspection at its subsidiary, Shilpa Pharma Life Sciences' Active Pharmaceutical Ingredient (API) manufacturing facility, Unit II, in Karnataka, according to an exchange filing.
 

Key Takeaways from Shilpa Medicare’s Inspection

• Shilpa Medicare announces the successful completion of ANVISA-Brazil inspection at its subsidiary, Shilpa Pharma Life Sciences' Active Pharmaceutical Ingredients.
• The inspection occurred at Raichur, Karnataka, between April 15 and 19, 2024.
• Following the successful assessment, ANVISA-Brazil received unit GMP accreditation.
   

From April 15 to April 19, 2024, Raichur, Karnataka, hosted the GMP inspection. ANVISA-Brazil certified the unit as GMP after a successful evaluation.
 

The company manufactures various oncology and non-oncology APIs. Shilpa Medicare remains committed to maintaining GMP status and quality standards as per the expectations and standards of Global Regulatory Authorities.
 

Raichur-based Shilpa Medicare is a manufacturer and distributor of quality drugs to global markets specialising in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.
 

About Shilpa Medicare Limited

Shilpa Medicare Limited develops, manufactures, and commercialises generic pharmaceutical products, active pharmaceutical ingredients (APIs), and formulations for both domestic and international markets. The company's product range spans both non-oncology and oncology therapeutic areas. The formulations are available in a variety of injectable and oral dose formats. The firm also provides contract research and production services for APIs, formulations, NDDS, speciality chemicals, and biotech goods. It exports pharmaceutical items to the United States, Europe, and other foreign markets. The firm has three research and development centres in India, two formulation factories, and two API plants. Shilpa Medicare is based in Raichur, Karnataka, India.

The CDSCO (Drug Controller General of India) approved the company's Tranexamic Acid Spray in September 2022. Furthermore, in November 2023, the firm announced the purchase of Pilnova Pharma Inc. In May, the company received US FDA clearance for the New Drug Application for Pemetrexed Injection 1000 mg/100 ml, 500 mg/50 ml, and 100 mg/10 ml. 

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