Natco Pharma Limited (NSE: NATCOPHARM, BSE: 524816) has announced a significant addition to its leadership team, appointing Mr. T.C. Mallikarjun as Vice President – Quality Control (QC) at their Pharma Division in Kothur, effective July 30, 2025. This strategic move aims to strengthen the company's quality control capabilities and regulatory compliance.

Experienced Professional Joins NATCO

Mr. Mallikarjun brings a wealth of experience from leading Indian pharmaceutical manufacturing industries. His expertise lies in handling regulatory inspections, including those from prominent global agencies such as the U.S. Food and Drug Administration (USFDA), Medicines and Healthcare products Regulatory Agency (MHRA), Therapeutic Goods Administration (TGA), and Brazilian Health Regulatory Agency (ANVISA).

Key Responsibilities and Expertise

In his new role, Mr. Mallikarjun will be responsible for overseeing quality control operations at NATCO's Kothur facility. His experience in managing new products and exhibit validations is expected to be valuable for the company's ongoing and future projects.

Previous Role and Transition

Prior to joining Natco Pharma, Mr. Mallikarjun held the position of Senior General Manager - Head QC at Aurobindo Pharma Limited, Hyderabad. This transition brings his extensive experience in quality control and regulatory affairs to NATCO's operations.

Appointment Details

The company has confirmed that the terms of Mr. Mallikarjun's appointment are in line with Natco Pharma's established policies. This appointment is part of NATCO's ongoing efforts to enhance its leadership team and maintain high standards of quality in its pharmaceutical operations.

Regulatory Compliance

Natco Pharma has duly informed the stock exchanges about this appointment, in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company's proactive disclosure aligns with its commitment to transparency and good corporate governance practices.

This strategic appointment underscores Natco Pharma's focus on strengthening its quality control processes and regulatory compliance capabilities, which are crucial in the highly regulated pharmaceutical industry.

Natco Pharma Limited (BSE: 524816, NSE: NATCOPHARM) has announced that its Active Pharmaceutical Ingredient (API) manufacturing unit in Mekaguda, Hyderabad, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA). The inspection, which took place from June 9th to June 13th, resulted in one observation classified as 'Voluntary Action Indicated' (VAI).

Inspection Details

The FDA conducted a thorough inspection of Natco Pharma's API facility in Mekaguda over a five-day period. Following the inspection, the company received a Form 483 with a single observation. The VAI classification suggests that while the FDA identified issues that should be addressed, they do not require immediate regulatory action.

Company's Response

Natco Pharma has acknowledged the receipt of the EIR on July 24th. The company stated in its regulatory filing that the U.S. FDA has issued the EIR for the API facility located in Mekaguda. This development indicates that the FDA has concluded its evaluation of the company's responses to the observation made during the inspection.

Implications for Natco Pharma

The receipt of an EIR with a VAI classification is generally considered a positive outcome for pharmaceutical companies. It suggests that while there are areas for improvement, the FDA does not see any critical issues that would impede the facility's operations or require more serious regulatory intervention.

About the Mekaguda Facility

The Mekaguda unit is one of Natco Pharma's key API manufacturing facilities. APIs are the primary ingredients used in the production of pharmaceutical drugs, making this facility crucial to Natco's supply chain and product development capabilities.

Natco Pharma's Global Presence

Natco Pharma is known for its strong presence in the pharmaceutical industry, with a focus on developing, manufacturing, and distributing generic and branded pharmaceuticals, specialty pharmaceuticals, and active pharmaceutical ingredients. The company operates nine manufacturing sites and two R&D facilities in India, catering to over 50 global markets.

The successful completion of the FDA inspection with a VAI classification for its Mekaguda API unit is likely to bolster Natco Pharma's standing in the global pharmaceutical market, particularly in regulated markets like the United States.

Investors and stakeholders will be watching closely to see how Natco Pharma addresses the FDA's observation and continues to maintain compliance with international regulatory standards.