Morepen Laboratories has successfully completed a United States Food and Drug Administration (USFDA) inspection at its Masulkhana facility in Himachal Pradesh, achieving zero observations and maintaining its track record of regulatory compliance. The company officially announced the inspection clearance through a regulatory filing to stock exchanges on April 17, 2026.

Official Announcement and Inspection Results

The pharmaceutical company announced that the USFDA inspection concluded with a Nil 483 status, indicating no regulatory observations or deficiencies were identified during the assessment. The inspection was successfully cleared on April 17, 2026, with the company formally notifying the National Stock Exchange of India and BSE Limited about the achievement through Company Secretary Vipul Kumar Srivastava.

Regulatory Compliance Excellence

This successful inspection represents Morepen Laboratories' fourth consecutive USFDA inspection without any observations over the past eight years, highlighting the company's consistent commitment to maintaining international pharmaceutical manufacturing standards. According to Executive Director Sanjay Suri, this achievement demonstrates the strength of the company's quality systems and team discipline in adhering to global standards, enhancing credibility with global regulators and paving the way for long-term supply contracts.

Strategic Market Position and Global Operations

The clean inspection status reinforces Morepen's position as a preferred partner for global pharmaceutical companies, successfully catering to regulated markets across the US, Europe, and other geographies. The company exports APIs to over 80 countries and maintains a strong presence in global supply chains, supported by regular customer audits and robust quality management systems aligned with current ICH and CFR guidelines.

Digital Transformation and Future Growth

Morepen continues to leverage its regulatory track record and technical expertise while strategically expanding into the Contract Development and Manufacturing Organization (CDMO) space. The company has invested significantly in digital systems, automation, and data integrity frameworks to ensure full compliance with global regulatory expectations and enhance operational efficiency across manufacturing processes.

Morepen Laboratories Limited has announced the complete closure of its credit facility arrangement with Kotak Mahindra Bank Limited, marking a significant financial milestone for the pharmaceutical company. The facility, worth Rs 99,00,00,000/- (Rupees Ninety Nine Crore Only), was fully repaid effective March 2, 2026.

Credit Facility Structure

The credit arrangement with Kotak Mahindra Bank comprised two distinct components that provided comprehensive working capital support to the company.

The secured working capital demand loan and cash credit limit were initially established to support the company's operational requirements and working capital needs.

Repayment Completion

Kotak Mahindra Bank has officially confirmed that the aforementioned facilities were fully repaid as of March 2, 2026. This confirmation was communicated to the company on March 11, 2026, demonstrating the successful completion of the repayment process.

Following the complete repayment, the bank is now undertaking the following procedural steps:

• Issuing a No Dues Certificate to formally acknowledge the settlement
• Releasing the assets that were charged as security for the facilities

Regulatory Compliance

The company has fulfilled its disclosure obligations under Regulation 30 by informing both the National Stock Exchange of India Limited and BSE Limited about this development. This intimation follows a previous communication dated December 18, 2024, which had originally disclosed the credit facility arrangement.

The complete repayment of this substantial credit facility reflects Morepen Laboratories' financial management capabilities and its commitment to meeting debt obligations in a timely manner.