Morepen Secures Fourth Consecutive USFDA Inspection with Zero Observations

Morepen Laboratories Limited (NSE: MOREPENLAB; BSE: 500288) today announced the successful completion of a United States Food and Drug Administration (USFDA) inspection at its Masulakhanna (HP) facility, with Zero observations (NIL Form 483).

This marks the Fourth consecutive NIL 483 inspection for Morepen over the past eight years, underscoring the Company's unwavering commitment to global quality and regulatory standards.

Strengthening Quality Systems and Compliance Culture

"Our consistent track record of NIL 483 inspections is a testament to the strength of our quality systems and our team's discipline in adhering to the highest global standards," said Sanjay Suri, Executive Director, Morepen Laboratories Limited. "This achievement enhances our credibility with global regulators, customers, and partners and paves the way for long term supply contracts".

The latest inspection outcome reflects Morepen's robust quality management systems, strong data integrity practices, and deep-rooted culture of regulatory compliance. The Company has consistently aligned its operations with evolving global standards, including current ICH and CFR (Part-21) guidelines, ensuring high levels of product quality, safety, and efficacy.

Driving Market Credibility and Customer Confidence

Morepen continues to be a preferred partner for global pharmaceutical companies, successfully catering to regulated markets across the US, Europe, and other geographies. The Company exports APIs and to over 80 countries, supported by regular and rigorous customer audits.

The consistent success in regulatory inspections further reinforces customer confidence and strengthens Morepen's positioning in highly regulated markets.

Digital Transformation and Data Integrity

Morepen has significantly invested in digital systems, automation, and data integrity frameworks, ensuring full compliance with global regulatory expectations. The Company's focus on digitalization enhances traceability, transparency, and operational efficiency across its manufacturing and quality processes.

Leadership in APIs and Expansion into CDMO

Morepen is a recognized market leader in six key Active Pharmaceutical Ingredients (APIs), with a strong presence in global supply chains. Building on this foundation, the Company is now strategically expanding into the CDMO space, aiming to leverage its regulatory track record, infrastructure, and technical expertise.

Shares of Morepen Laboratories Limited was last trading in BSE at Rs. 41.92 as compared to the previous close of Rs. 41.13. The total number of shares traded during the day was 469635 in over 1288 trades.

The stock hit an intraday high of Rs. 43.06 and intraday low of 41.00. The net turnover during the day was Rs. 19691323.00.

Source : Equity Bulls

Keywords

MorepenLaboratories INE083A01026 Pharmaceuticals USFDA Inspection ZeroObservations