Alivus Life Sciences Limited , formerly known as Glenmark Life Sciences Limited, has announced a significant regulatory milestone for its API manufacturing facility in Gujarat. The company received an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) classification from the U.S. Food and Drug Administration (USFDA) for its facility located in Dahej, Gujarat.

Inspection Details

The USFDA conducted an inspection of the API manufacturing facility from May 26 to May 30. Following this inspection, the regulatory body issued the EIR with an NAI classification, indicating that the facility met all necessary regulatory standards during the inspection process.

Facility Information

The inspected facility is situated at Z-103/I, SEZ, Phase II, District Bharuch, Dahej - 392 130, Gujarat. This site plays a crucial role in Alivus Life Sciences' API (Active Pharmaceutical Ingredients) manufacturing operations.

Regulatory Significance

An NAI classification from the USFDA is considered a positive outcome for pharmaceutical companies. It signifies that no objectionable conditions or practices were observed during the inspection, and no corrective actions are required from the company. This status is important for maintaining the facility's ability to manufacture and supply APIs to the U.S. market.

Company Statement

Alivus Life Sciences Limited officially communicated this development to the stock exchanges on July 26, in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company's Company Secretary & Compliance Officer, Rudalf Corriea, signed the official intimation.

About Alivus Life Sciences Limited

Alivus Life Sciences Limited, which changed its name from Glenmark Life Sciences Limited, is a key player in the pharmaceutical industry, specializing in the development and manufacture of APIs. The company's corporate office is located in Mumbai, while its registered office is in Solapur, Maharashtra.

This regulatory success underscores Alivus Life Sciences' commitment to maintaining high-quality standards in its manufacturing processes and strengthens its position in the global pharmaceutical supply chain.

Alivus Life Sciences has demonstrated its commitment to quality and regulatory compliance as it successfully navigated a crucial United States Food and Drug Administration (USFDA) inspection. The company's Active Pharmaceutical Ingredient (API) facility in Dahej, Gujarat, emerged from the regulatory review with flying colors, receiving zero Form 483 observations.

Inspection Highlights

• Zero Form 483 Observations: The USFDA inspection concluded without any Form 483 observations, a significant achievement that underscores the facility's adherence to Good Manufacturing Practices (GMP).
• Facility Location: The inspection took place at Alivus Life Sciences' API facility in Dahej, an important manufacturing hub for the company.
• Regulatory Significance: A Form 483 is issued when inspectors observe conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Receiving no observations is a testament to the facility's high standards.

Implications for Alivus Life Sciences

The successful completion of the USFDA GMP inspection without any observations is a notable accomplishment for Alivus Life Sciences. This outcome:

• Validates Quality Systems: Demonstrates the robustness of the company's quality management systems and manufacturing processes.
• Enhances Market Position: Potentially strengthens Alivus Life Sciences' position in the global pharmaceutical market, particularly for products destined for the U.S. market.
• Regulatory Confidence: Builds confidence among regulators, partners, and customers in the company's ability to consistently produce high-quality APIs.

Industry Context

In the pharmaceutical industry, regulatory inspections, especially those conducted by the USFDA, are critical milestones. They ensure that drug manufacturers comply with stringent quality standards and Good Manufacturing Practices. A successful inspection without any observations is often seen as a mark of excellence and can have positive implications for a company's reputation and business prospects.

Alivus Life Sciences' achievement at its Dahej API facility reflects well on its operational standards and quality control measures. As the pharmaceutical landscape continues to evolve with increasing regulatory scrutiny, such accomplishments can provide companies with a competitive edge in the global market.