SMS Pharmaceuticals has announced the incorporation of its wholly owned subsidiary, SMSco Lab Private Limited, with an authorized capital of ₹15.00 lakh. The new entity is set to manufacture pharmaceutical products in new therapeutic categories.

Subsidiary Details and Capital Structure

SMSco Lab Private Limited has been incorporated with the following financial parameters:

Business Objectives and Operations

The newly incorporated subsidiary will operate as a greenfield project focused on manufacturing pharmaceutical products in new therapeutic categories. The main business objectives include comprehensive pharmaceutical operations spanning the entire value chain.

The subsidiary's core activities will encompass:

• Research, development, formulation, marketing, and production of pharmaceuticals
• Manufacturing and commercialization of intermediates, drugs, bulk drugs, and medicines
• Development of newer medicines for various therapeutic uses
• Manufacturing, importing, exporting, and trading of pharmaceutical products and active pharmaceutical ingredients
• Production and distribution of chemicals, surgical, medical, and scientific equipment

Strategic Vision and Market Expansion

SMSco Lab Private Limited aims to establish and maintain strategic partnerships and joint ventures globally. This approach is designed to expand market reach and enhance product offerings in the pharmaceutical formulations sector, while investing in and managing assets necessary for achieving the company's objectives.

Corporate Structure and Leadership

The subsidiary maintains close ties with its parent company through shared leadership. Mr. Vamsi Krishna Potluri, who serves as Executive Director at SMS Pharmaceuticals Limited, has been appointed as Director of SMSco Lab Private Limited, ensuring continuity in strategic direction and operational oversight.

Regulatory Compliance

The incorporation represents a related party transaction, with SMS Pharmaceuticals holding 100% equity stake in the subsidiary. The company has fulfilled all disclosure requirements under Regulation 30 of the SEBI (LODR) Regulations, 2015, and SEBI Circular No. SEBI/HO/CFD/PoD2/CIR/P/0155 dated November 11, 2024. As a newly incorporated entity, SMSco Lab Private Limited is yet to commence business operations and has no applicable turnover at this stage.

SMS Pharmaceuticals has successfully completed a United States Food and Drug Administration (USFDA) inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility in Visakhapatnam, Andhra Pradesh. The inspection, conducted from December 08 to December 12, 2025, concluded with only one minor procedural observation recorded in Form 483.

Inspection Details and Results

The USFDA inspection focused on the company's flagship API manufacturing facility at Vizag. According to the company's official statement, the single observation noted during the inspection is procedural in nature and does not relate to data integrity concerns.

Facility Specifications

The Vizag facility represents SMS Pharmaceuticals' flagship manufacturing unit with significant operational capabilities. The facility is designed as a multipurpose API manufacturing plant specializing in niche, large-volume molecules.

Management Commentary

P. Vamsi Krishna, Executive Director of SMS Pharmaceuticals, commented on the achievement: "The successful completion of the USFDA inspection reaffirms our commitment to stringent quality, compliance, and global regulatory standards. This marks the 4th inspection for this facility and the 12th across our manufacturing sites, including two audits of our Central Laboratory Analytical Services (CLAS)."

The executive emphasized that this milestone further reinforces the company's position as a reliable partner to global pharmaceutical companies and ensures continued, high-quality API supply to key international markets.

Regulatory Compliance Framework

The successful inspection outcome demonstrates SMS Pharmaceuticals' robust regulatory compliance framework. The company will provide the necessary response to USFDA within the stipulated time period for the minor procedural observation noted during the inspection.

This regulatory milestone strengthens the company's manufacturing credentials and maintains its access to regulated international markets, particularly important for its operations serving customers across over 75 countries.