Brazilian Regulators successfully completes GMP Audit of Alembic Pharma

Alembic's API-II facility at Panelav successfully completed the rigorous ANVISA GMP audit

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GMP Good Manufacturing Practice
GMP

Last Updated on December 16, 2024 by The Health Master

GMP Audit

Alembic Pharmaceuticals, a leading pharmaceutical company, has successfully cleared a crucial hurdle in its global expansion plans by completing GMP audit.

The company recently announced that its API-II facility at Panelav has successfully passed the Good Manufacturing Practices audit (GMP audit) conducted by the Brazilian Health Regulatory Agency (ANVISA).  

ANVISA GMP Approval: A Significant Milestone

The ANVISA GMP approval is a significant milestone for Alembic Pharmaceuticals.

This certification validates the company’s commitment to quality, safety, and regulatory compliance.

By achieving this certification, Alembic can now expand its market reach in Brazil, a key market for pharmaceutical products.

Key Takeaways

  • Successful ANVISA GMP Audit: Alembic’s API-II facility at Panelav successfully completed the rigorous ANVISA GMP audit.  
  • Expanded Market Access: The approval will enable Alembic to export its high-quality APIs to the Brazilian market.
  • Strengthened Global Presence: This achievement further solidifies Alembic’s position as a global pharmaceutical player.

About Alembic Pharmaceuticals

Alembic Pharmaceuticals is a renowned pharmaceutical company with a strong focus on research and development, manufacturing, and marketing of a diverse range of pharmaceutical products.

The company’s product portfolio includes generic drugs, active pharmaceutical ingredients (APIs), and over-the-counter (OTC) products.  

With a global presence spanning over 75 countries, Alembic is dedicated to providing affordable and high-quality medicines to patients worldwide.

The company’s therapeutic focus areas include cardiovascular, anti-infective, pain management, and oncology.

By securing ANVISA GMP approval, Alembic Pharmaceuticals has taken a significant step towards strengthening its global presence and delivering high-quality medicines to patients worldwide.

Q: What is ANVISA GMP?

A: ANVISA GMP is a regulatory standard set by the Brazilian Health Regulatory Agency (ANVISA) to ensure the quality, safety, and efficacy of pharmaceutical products manufactured in Brazil.  

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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