Sun Pharma shares decline by 1.9%; after four observations reported from US FDA

The shares of Sun Pharmaceutical Industries Limited (Sun Pharma) showed a decline in its share price by 1.9% to ₹1,462.50 on the NSE on Thursday, 30 May, 2024. This decline is followed by the reports issued by the US Food and Drug Administration (US FDA) during an inspection of their Dahej facility.

The US FDA organised an inspection between 10 May 2024 and 17 May 2024, and subsequently issued a Form 483 listing four major observations related to the company’s compliance with manufacturing standards, as per the reports by CNBC-TV18.

The observations highlighted shortcomings in several areas that included:

1. Lack of documentation: The routine maintenance held in the facility was not documented. It could potentially indicate problems with the maintenance of the equipment and consistency in the manufacturing processes.
2. Failure to identify impurity reference standards: Not analysing impurity reference standards may lead to issues with accurately detecting and quantifying impurities in the products offered by the company.
3. Lack of documentation for material sampling methods: Not documenting the sampling methods may raise questions about the accuracy and reliability of the company’s quality control procedures.
4. Inadequate precautions preventing API contamination: The precautions aren’t laid down and therefore, it raises concerns about the potential for product quality issues and safety risks.

Sun Pharma’s facility at Dahej is an important component of the company’s operations as it plays a significant role in its export to the primary market located in the US. The company’s performance had seen a notable impact due to non-compliance with US FDA regulations. Sun Pharma stays muted on the issued US FDA observations.

Shares of Sun Pharmaceuticals Limited closed 0.93% lower at ₹1,465.20 apiece on the NSE.