Piramal Pharma Limited has disclosed that the US FDA conducted a routine Good Manufacturing Practices (GMP) inspection at its Digwal facility in Telangana, India. The inspection, which took place from February 9, 2026 to February 13, 2026, resulted in the issuance of a Form-483 with specific observations.

Inspection Details and Outcomes

The regulatory filing revealed key details about the FDA inspection and its conclusions:

Nature of Observations

The company clarified that the 4 observations identified by the US FDA are specifically related to enhancement in procedures and are not connected to data integrity issues. This distinction is significant as data integrity concerns typically carry more serious regulatory implications. The observations have been classified as VAI (voluntary action indicated), which represents a moderate level of regulatory concern requiring corrective action.

Company Response and Compliance Commitment

Piramal Pharma Limited has indicated that it is actively preparing a comprehensive response to address all the observations raised by the US FDA. The company plans to submit this detailed response within the stipulated timelines as required by regulatory protocols.

The pharmaceutical company emphasized its commitment to maintaining the highest standards of compliance and stated that it will work closely with the regulatory agency to comprehensively address all the observations. This collaborative approach demonstrates the company's proactive stance toward regulatory compliance and quality assurance.

Regulatory Context

The disclosure was made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, which mandates listed companies to inform stock exchanges about material events that could impact investor decisions. The transparency in reporting such regulatory inspections reflects the company's adherence to disclosure norms and commitment to keeping stakeholders informed about operational developments.

Piramal Pharma Limited has received positive regulatory news as the Gujarat Pollution Control Board (GPCB) granted interim revocation of closure directions for its Dahej manufacturing facility, allowing the company to resume operations with immediate effect.

Latest Development - Operations Resume

The GPCB, through its letter dated 13th February 2026, granted interim revocation of the closure directions that were previously issued under Section 33-A of the Water (Prevention and Control of Pollution) Act, 1974. This development allows Piramal Pharma to restart operations at its Dahej Site immediately.

Previous Regulatory Challenges

This positive development follows a series of regulatory actions that began in early February 2026. The company had previously received closure directions from GPCB on 4th February 2026, followed by an interim environmental damage compensation notice of Rs 1 crore on 10th February 2026.

Company's Commitment to Compliance

Piramal Pharma has expressed its commitment to working with GPCB to ensure that the interim directions are made final in due course. The company continues to engage with regulatory authorities to address environmental compliance matters at the facility.

Regulatory Disclosure Framework

The company made this disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, communicating the development to both BSE Limited and the National Stock Exchange of India Limited. The disclosure was signed by Company Secretary Tanya Sanish on 14th February 2026.