SMS Pharmaceuticals Limited (SMS Pharma) has announced a significant regulatory milestone for its Central Laboratory Analytical Services facility in Hyderabad. The company has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) with a 'No Action Indicated' (NAI) status, indicating a successful closure of the recent inspection.

Inspection Details

The USFDA conducted an inspection of SMS Pharma's Central Laboratory Analytical Services located at Gagillapur Village, Medchal Malkajgiri District, Hyderabad, Telangana, from June 23 to June 25, 2025. The inspection concluded with zero Form 483 observations, a fact that the company had previously communicated to the stock exchanges.

Significance of the EIR

The receipt of an EIR with NAI status is a positive outcome for SMS Pharma. This classification signifies that the FDA found no significant regulatory violations during their thorough inspection of the laboratory facility. It serves as a testament to the company's commitment to maintaining high standards of quality and regulatory compliance.

Management's Perspective

Mr. P. Vamsi Krishna, Executive Director of SMS Pharmaceuticals Limited, commented on this achievement: "The successful completion of the recent USFDA inspection underscores our unwavering commitment to the highest standards of quality, regulatory compliance, and operational excellence across our manufacturing and analytical facilities. This positive outcome reinforces the confidence of our global partners and stakeholders, while further enabling our strategic growth and sustained presence in key regulated markets."

Company Overview

SMS Pharmaceuticals Limited, established in 1990, is a diversified and integrated pharmaceutical company specializing in API (Active Pharmaceutical Ingredients) and intermediates for global customers. The company operates two state-of-the-art manufacturing facilities in Hyderabad and Vizag, with capacities of 120 KL and 3,000 KL, respectively. Supported by strong in-house R&D capabilities, SMS Pharma has built a reputation for delivering quality products across various therapeutic segments, serving as a trusted partner to a global customer base in over 70 countries.

Market Impact

This favorable inspection outcome is likely to bolster SMS Pharma's position in the pharmaceutical industry, particularly in regulated markets. The NAI status from the USFDA enhances the company's credibility and may potentially open up new opportunities for growth and partnerships in the global pharmaceutical landscape.

As the pharmaceutical sector continues to face stringent regulatory scrutiny, SMS Pharma's ability to meet USFDA standards without any significant observations highlights its robust quality management systems and operational excellence.

SMS Pharmaceuticals , a prominent player in the pharmaceutical industry, has seen a significant change in its shareholding structure. Vistra ITCL (India) Limited, acting in its capacity as a Debenture Trustee, has increased its stake in the company through a share pledge transaction.

Key Highlights

• Vistra ITCL acquired 30,00,000 shares of SMS Pharmaceuticals through encumbrance or pledge.
• The acquisition represents 3.38% of SMS Pharmaceuticals' total share capital.
• Vistra's total shareholding in SMS Pharmaceuticals increased from 21.53% to 24.91% following this transaction.

Transaction Details

Vistra ITCL (India) Limited, in its role as a Debenture Trustee, received a pledge of 30,00,000 equity shares of SMS Pharmaceuticals Limited. This pledge increased Vistra's holding in the company by 3.38 percentage points, bringing their total stake to 24.91% of the company's share capital.

Company Overview

SMS Pharmaceuticals Limited has an equity share capital comprising 8,86,52,030 shares, each with a face value of Rs. 1. The company's shares are listed on both the BSE Limited and the National Stock Exchange of India Limited.

Shareholding Structure

The following table illustrates the change in Vistra ITCL's shareholding in SMS Pharmaceuticals:

Regulatory Compliance

Vistra ITCL has made this disclosure as a precautionary measure in its capacity as security trustee and debenture trustee. The company clarified that while the primary compliance responsibility lies with the lender and debenture holder, they have taken this step to ensure transparency and adherence to regulatory requirements.

The disclosure was made under Regulation 29(2) of SEBI (Substantial Acquisition of Shares and Takeovers) Regulations, 2011, demonstrating the company's commitment to maintaining open communication with its shareholders and regulatory bodies.

This development marks a significant shift in the ownership structure of SMS Pharmaceuticals Limited and may be of interest to investors and market analysts tracking the pharmaceutical sector.