Piramal Pharma has received a US FDA Form-483 for its Lexington facility following a Good Manufacturing Practices (GMP) inspection. The pharmaceutical company disclosed that the inspection identified four regulatory observations that will be classified as VAI (Voluntary Action Indicated).

FDA Inspection Details

The US FDA conducted a comprehensive GMP inspection at Piramal Pharma's Lexington facility in Kentucky, USA. At the conclusion of the inspection, the regulatory authority issued Form-483 documenting four observations related to enhancement in procedures.

Company Response and Compliance

Piramal Pharma has confirmed that it is preparing a detailed response to address all observations identified during the inspection. The company stated it will submit this comprehensive response to the US FDA within the stipulated regulatory timelines. The observations are specifically related to procedural enhancements rather than critical manufacturing deficiencies.

Regulatory Classification

The VAI (Voluntary Action Indicated) classification indicates that the FDA found objectionable conditions during the inspection, but the agency is not prepared to take or recommend any administrative or regulatory action. This classification is less severe than an Official Action Indicated (OAI) status, which would require more immediate and stringent corrective measures.

Commitment to Standards

The company emphasized its commitment to maintaining the highest standards of compliance and stated it will work closely with the FDA to comprehensively address all observations. This approach demonstrates Piramal Pharma's dedication to regulatory compliance and quality manufacturing standards at its US operations.

Piramal Pharma Limited has issued a postal ballot notice seeking shareholder approval for the appointment of Mr. Amit Soni as an Independent Director. The company announced the formal voting process through a regulatory filing under Regulation 30 of SEBI Listing Regulations.

Postal Ballot Details

Director Appointment Proposal

The Board has approved the appointment of Mr. Amit Soni (DIN: 05111144) as a Non-Executive Independent Director for a five-year term. The appointment requires shareholder approval through a special resolution as mandated under SEBI Listing Regulations.

About Amit Soni

Mr. Soni brings extensive investment experience to Piramal Pharma's board. As a Partner at CVC Capital, he established the firm's India operations and has led significant investments across multiple sectors.

Professional Background

Educational Qualifications

Voting Process

The company will conduct voting exclusively through remote e-voting, with no physical ballot forms being distributed. Members whose email addresses are registered with the company or depositories will receive the notice electronically. The postal ballot notice includes detailed instructions for accessing the NSDL e-voting platform.

Current Directorships

Mr. Soni currently serves on the boards of several companies including Cohizon Life Sciences Limited, CVC Advisers (India) Private Limited, and Irelia Sports India Private Limited. He also holds committee positions in statutory committees of these organizations.

The appointment aligns with the company's commitment to strengthening its board composition with experienced professionals who can contribute to strategic decision-making and corporate governance.