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.

SMS Pharmaceuticals Limited has announced a significant development for its associate company, VKT Pharma. The US Food and Drug Administration (FDA) has granted approval for VKT Pharma's reformulated Ranitidine tablets in 150mg and 300mg strengths, marking a crucial milestone for both companies.

Key Highlights

• FDA Approval: VKT Pharma, an associate of SMS Pharmaceuticals, receives US FDA approval for reformulated Ranitidine tablets.
• Product Strengths: Approved in 150mg and 300mg dosages.
• Market Re-entry: Marks the return of this important acid-reducing medication to the US market after a five-year hiatus.
• Safety Improvements: Extensive safety testing and manufacturing enhancements address previous concerns about NDMA impurity formation.
• Patient Impact: Expected to increase access to this vital medication for patients with various health conditions.

Significance of the Approval

The approval of reformulated Ranitidine is a noteworthy achievement for VKT Pharma and, by extension, for SMS Pharmaceuticals. This development is particularly significant given the previous concerns that led to the withdrawal of Ranitidine products from the US market. The successful reformulation and subsequent FDA approval demonstrate the companies' commitment to product safety and quality.

Financial Implications

While the direct financial impact on SMS Pharmaceuticals is not immediately quantifiable, this approval could potentially contribute to the company's growth. The company reported the following key financial metrics:

The company's strong asset growth and equity position suggest it is well-positioned to capitalize on new opportunities, such as the potential revenue streams from VKT Pharma's newly approved product.

Market Implications

The re-introduction of Ranitidine to the US market could have significant implications for the pharmaceutical industry, particularly in the gastrointestinal medication segment. As an acid-reducing medication, Ranitidine serves an important role in treating various conditions, and its return to the market after addressing safety concerns may be welcomed by healthcare providers and patients alike.

Looking Ahead

As VKT Pharma prepares to bring its reformulated Ranitidine to the US market, stakeholders will be keen to observe the product's reception and its impact on both VKT Pharma and SMS Pharmaceuticals. The successful navigation of regulatory hurdles and the addressing of previous safety concerns position this development as a potential catalyst for growth and enhanced market presence in the pharmaceutical sector.

Investors and industry observers will likely monitor the rollout of the reformulated Ranitidine closely, as it may provide insights into the companies' capabilities in product development, quality control, and market responsiveness.