Alembic Pharmaceuticals Limited (Alembic Pharma) has achieved a significant milestone in its quality assurance efforts. The company's Active Pharmaceutical Ingredient (API) manufacturing facility, API-III, located in Karakhadi, has successfully passed a rigorous inspection by the United States Food and Drug Administration (USFDA).

Inspection Outcome

The scheduled Good Manufacturing Practice (GMP) inspection conducted by the USFDA concluded on a highly positive note. Notably, the inspection was completed without any Form 483 observations, which is a testament to the facility's adherence to high-quality standards and regulatory compliance.

Significance of No Form 483 Observations

The absence of Form 483 observations is particularly noteworthy in the pharmaceutical industry. When the FDA conducts an inspection and finds no significant objectionable conditions or practices, it does not issue a Form 483. This outcome indicates that:

• The facility maintains excellent manufacturing practices
• Quality control processes are robust and effective
• The company's operations align well with FDA regulations

Implications for Alembic Pharmaceuticals

This successful inspection outcome has several positive implications for Alembic Pharmaceuticals:

1. Regulatory Compliance: It reinforces the company's commitment to maintaining high standards of quality and regulatory compliance.

2. Market Confidence: A clean FDA inspection can boost confidence among stakeholders, including customers, partners, and investors.

3. Operational Continuity: The successful inspection ensures that the API-III facility can continue its operations without any regulatory hurdles, potentially supporting uninterrupted supply chains.

4. Competitive Advantage: In the highly regulated pharmaceutical industry, such achievements can provide a competitive edge and potentially open doors to new business opportunities.

About the Facility

The API-III facility in Karakhadi is one of Alembic Pharmaceuticals' key manufacturing units. It specializes in the production of Active Pharmaceutical Ingredients, which are crucial components in the manufacture of various drugs.

Conclusion

This successful USFDA inspection underscores Alembic Pharmaceuticals' ongoing commitment to quality and regulatory excellence in its manufacturing processes. As the pharmaceutical landscape continues to evolve with increasing regulatory scrutiny, such achievements play a vital role in maintaining the company's standing in the global pharmaceutical market.

Alembic Pharmaceuticals Limited has announced a significant milestone in its regulatory compliance efforts. The company successfully completed a scheduled Good Manufacturing Practice (GMP) inspection by the U.S. Food and Drug Administration (USFDA) at its API-III facility in Karakhadi, Gujarat.

Inspection Details

The inspection, which took place from March 17 to March 21, 2025, concluded without any Form 483 observations. This outcome indicates that the USFDA inspectors did not identify any significant objectionable conditions or practices during their thorough examination of the facility.

Importance of the Outcome

A Form 483-free inspection is a notable achievement in the pharmaceutical industry, as it suggests that the facility maintains high standards of manufacturing practices that align with USFDA requirements. This positive result can have several implications for Alembic Pharmaceuticals:

1. Regulatory Compliance: It demonstrates the company's commitment to maintaining strict quality control and adherence to international regulatory standards.

2. Market Confidence: A successful USFDA inspection can boost confidence among stakeholders, including customers, partners, and investors.

3. Operational Continuity: The clean inspection allows for uninterrupted operations at the API-III facility, which is crucial for the company's supply chain and production capabilities.

About the Facility

The API-III facility at Karakhadi is an important part of Alembic Pharmaceuticals' manufacturing infrastructure. APIs, or Active Pharmaceutical Ingredients, are the key components in drug manufacturing, making the facility's compliance with international standards particularly significant.

Company's Disclosure

In line with regulatory requirements, Alembic Pharmaceuticals promptly disclosed this information to the stock exchanges. Manisha Saraf, Company Secretary of Alembic Pharmaceuticals Limited, signed the official communication to both the BSE Limited and the National Stock Exchange of India Ltd.

This successful inspection adds to Alembic Pharmaceuticals' track record in regulatory compliance and quality management, potentially strengthening its position in the global pharmaceutical market.