Ajanta Pharma Limited has informed stock exchanges that the US FDA inspection at its manufacturing facility in Paithan, Maharashtra has concluded with the issuance of Form-483. The pharmaceutical company disclosed this development through a regulatory filing under Regulation 30 of SEBI Listing Regulations on April 22, 2026.

Inspection Details

The US FDA inspection was conducted over a period of nine days at the company's Paithan manufacturing facility. The regulatory examination covered various aspects of the manufacturing operations and compliance standards.

Regulatory Compliance

Form-483 is a standard document issued by the US FDA that lists observations made during facility inspections. The document typically highlights areas where the agency believes the company may not be in compliance with FDA regulations or good manufacturing practices.

Company Response

Ajanta Pharma has stated that it will respond to the US FDA within the stipulated timeline as required by regulatory protocols. The company's response will address each of the 5 observations noted in the Form-483 document.

Disclosure Requirements

The announcement was made pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015. The disclosure was signed by Gaurang Shah, Senior Vice President – Legal & Company Secretary, ensuring compliance with mandatory reporting requirements for listed companies.

Ajanta Pharma Limited has submitted its quarterly compliance certificate under SEBI (Depositories and Participants) Regulations, 2018 to stock exchanges for the quarter ended 31st March 2026. The pharmaceutical company filed the mandatory certificate on 6th April 2026, demonstrating its commitment to regulatory compliance.

Regulatory Compliance Certificate Details

The certificate was issued under Regulation 74(5) of the SEBI (Depositories and Participants) Regulations, 2018 by MUFG Intime India Private Limited, formerly known as Link Intime India Private Limited, which serves as the company's registrar and share transfer agent.

Certificate Confirmation Process

MUFG Intime India Private Limited confirmed that all securities received from depository participants for dematerialisation during the quarter were properly processed according to regulatory requirements. The registrar verified that:

• Securities received for dematerialisation were confirmed or rejected to depositories within prescribed timelines
• Security certificates comprised in dematerialisation requests have been listed on stock exchanges where existing securities are traded
• Physical security certificates received were mutilated and cancelled after proper verification
• Depository names were substituted in the register of members as registered owners

Corporate Governance and Compliance

The submission was signed by Gaurang Shah, Senior Vice President - Legal & Company Secretary of Ajanta Pharma, while the certificate was issued by Ashok Shetty, Senior Vice President-Corporate Registry at MUFG Intime India Private Limited. This quarterly filing represents part of the company's ongoing regulatory compliance obligations under SEBI guidelines for listed companies.

The certificate filing ensures transparency in the dematerialisation process and confirms that all procedural requirements have been met during the reporting quarter, maintaining investor confidence in the company's operational compliance standards.