Unichem Laboratories has completed a regulatory inspection by the US Food and Drug Administration (USFDA) at its Kolhapur manufacturing facility. The inspection process concluded with the regulatory authority issuing five observations, while notably finding no data integrity issues at the facility.

Inspection Outcome Details

The USFDA inspection represents a routine regulatory review of the company's manufacturing operations and quality systems. The completion of the inspection with a limited number of observations indicates that the facility's operations align with regulatory requirements.

Regulatory Compliance Significance

The absence of data integrity issues during the inspection is particularly significant for pharmaceutical manufacturers, as data integrity concerns can lead to more serious regulatory actions. The five observations noted by the USFDA represent areas for improvement but do not indicate major compliance violations.

For pharmaceutical companies operating in international markets, successful completion of regulatory inspections is essential for maintaining manufacturing licenses and market access. The outcome of this inspection supports the company's continued operations at the Kolhapur facility and its ability to serve both domestic and international markets.

Unichem laboratories has informed stock exchanges about a voluntary product recall by its US subsidiary under regulatory disclosure requirements. The pharmaceutical company's wholly-owned subsidiary, Unichem Pharmaceuticals (USA), Inc., has initiated recalls for two products distributed in the American market.

Product Recall Details

The recall encompasses two distinct pharmaceutical products with specific quality-related issues:

Safety and Quality Assurance

The company has confirmed that no adverse events related to these recalls have been reported to date. Unichem Laboratories emphasized its commitment to patient safety, stating that the company places the highest priority on ensuring patient safety and maintaining product quality throughout every stage of its manufacturing and supply chain processes.

Regulatory Compliance

The disclosure was made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The communication was addressed to both the National Stock Exchange of India Limited (Symbol: UNICHEMLAB) and BSE Limited (Script Code: 506690) on 27th January 2026.

Company Response

The voluntary nature of these recalls demonstrates the company's proactive approach to quality management and regulatory compliance. By initiating these recalls independently, Unichem Pharmaceuticals (USA), Inc. has taken preventive measures to address potential quality concerns before they could impact patient safety or treatment outcomes.