Alkem Laboratories has announced that the United States Food and Drug Administration (USFDA) completed a Pre-Approval Inspection (PAI) at the manufacturing facility of its subsidiary Enzene Biosciences Limited in India. The inspection concluded with regulatory observations that require the company's attention and response.

USFDA Inspection Results

Following the completion of the inspection, the USFDA issued a Form 483 document containing specific observations about the facility's operations. The regulatory findings provide important insights into the inspection outcome and areas requiring attention.

Quality Systems Validation

A significant highlight of the inspection was Enzene's achievement of zero observations related to data integrity. The company emphasized this outcome as critical validation of Enzene's quality systems and the reliability of its regulatory filings. Data integrity represents a fundamental aspect of pharmaceutical manufacturing compliance and regulatory acceptance.

Corrective Action Response

Enzene Biosciences is actively preparing its formal response to address the USFDA observations. The subsidiary has initiated appropriate corrective and preventive actions to address the 6 procedural observations identified during the inspection. The company is working within the stipulated timeline to submit its comprehensive response to the regulatory authority.

Regulatory Compliance Framework

The Pre-Approval Inspection represents a standard regulatory process conducted by the USFDA to evaluate manufacturing facilities before approving pharmaceutical products. The Form 483 document serves as an official communication tool for conveying inspection observations that require company attention and response. Alkem Laboratories has formally notified stakeholders about this regulatory development as part of its compliance obligations under Regulation 30.

Alkem Laboratories Limited has entered into an Amendment cum Supplemental Agreement dated 13th February, 2026 with its subsidiary Enzene Biosciences Limited and key investors. The agreement involves Eight Roads Ventures India Healthcare IV, L.P., F-Prime Capital Partners Life Sciences Fund VI LP, and ERVI Healthcare IV Holdings Limited for strategic fund infusion and governance amendments.

Agreement Structure and Fund Infusion

The Amendment cum Supplemental Agreement facilitates three key objectives: the allotment of securities by Enzene to F-Prime Capital and ERVI Healthcare on a preferential basis through private placement, adherence by ERVI Healthcare to the existing Shareholders' Agreement terms, and amendment of certain provisions of the original Shareholders' Agreement.

Securities Allocation Details

Under the preferential allotment arrangement, F-Prime Capital will subscribe to 1,30,451 Series B Compulsorily Convertible Preference Shares, while ERVI Healthcare will acquire 4,27,851 Series B CCPS along with 10 equity shares. Each security carries a face value of Rs. 10.00 and is priced at Rs. 468.60, including a premium of Rs. 458.60 per share.

Post-Allotment Shareholding Structure

Following the completion of the preferential allotment, the shareholding pattern in Enzene Biosciences will be restructured on a fully diluted basis:

Regulatory Compliance and Background

This disclosure follows Alkem's earlier intimations dated 23rd December, 2022 regarding the original Shareholders' Agreement and 11th August, 2023 concerning liability creation. The current amendment ensures ERVI Healthcare's adherence to the Shareholders' Agreement terms while facilitating the strategic investment in Enzene Biosciences.

Strategic Implications

The agreement maintains Alkem's controlling stake in its subsidiary Enzene Biosciences at 88.99% while bringing in additional capital and strategic partnerships. The transaction does not fall within related party transaction purview and has no impact on Alkem's management or control structure. The fund infusion strengthens Enzene's financial position for its biosciences operations and growth initiatives.