Alivus Life Sciences Limited , formerly known as Glenmark Life Sciences Limited, has received a significant boost in its regulatory compliance efforts. The company announced that it has obtained an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) classification from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility.

Inspection Details

The USFDA conducted an inspection of Alivus Life Sciences' API manufacturing facility located at Z-103/I, SEZ, Phase II, District Bharuch, Dahej - 392 130, Gujarat. The inspection took place from May 26 to May 30, 2025, as part of the regulatory body's ongoing oversight of pharmaceutical manufacturing facilities.

No Action Indicated (NAI) Classification

The NAI classification is a positive outcome for Alivus Life Sciences, indicating that the facility met regulatory standards during the inspection. This classification suggests that no objectionable conditions or practices were observed during the USFDA's visit, and no further actions are required from the company in response to the inspection.

Implications for Alivus Life Sciences

Receiving an NAI classification from the USFDA is a significant achievement for pharmaceutical companies, as it demonstrates compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. This positive outcome could potentially:

• Enhance the company's reputation in the global pharmaceutical market
• Strengthen its position as a reliable API manufacturer
• Open doors for new business opportunities, especially in the US market

Company Statement

In its official communication to the stock exchanges, Alivus Life Sciences stated, "This is to inform you that the USFDA has issued an Establishment Inspection Report ("EIR") with a No Action Indicated ("NAI") classification for the said manufacturing facility."

The successful USFDA inspection and subsequent NAI classification underscore Alivus Life Sciences' commitment to maintaining high-quality standards in its API manufacturing processes. As the pharmaceutical industry continues to face stringent regulatory scrutiny, such positive outcomes can be crucial for companies looking to establish themselves as trusted suppliers in the global market.

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.