SMS Pharmaceuticals Limited (NSE: SMSPHARMA; BSE: 532815), a leading Indian pharmaceutical company, has achieved a major regulatory milestone. The company's Unit VII manufacturing facility located in Visakhapatnam, Andhra Pradesh, has received prequalification approval from the World Health Organisation (WHO), Geneva. This approval significantly enhances SMS Pharma’s global standing, particularly in the production and export of Anti-Retroviral (ARV) Active Pharmaceutical Ingredients (APIs).

This move not only boosts the company’s reputation for adhering to international quality and safety standards, but also opens doors to expanded market opportunities in global healthcare programs, especially in regions relying on WHO-approved suppliers for life-saving treatments.

What WHO Prequalification Means for Pharma Manufacturers

WHO Prequalification is a globally respected certification that evaluates pharmaceutical manufacturing facilities for compliance with international quality, safety, and efficacy standards. A facility that earns this recognition is considered reliable for producing APIs or finished pharmaceutical products that are eligible for procurement by global health organisations like UNICEF, UNITAID, and the Global Fund.

For SMS Pharma, this certification indicates that its Vizag plant is equipped with state-of-the-art infrastructure and processes that meet WHO’s stringent regulatory benchmarks. The recognition is crucial for supplying ARV APIs used in the treatment of HIV/AIDS, a major focus area for international health efforts.

Strengthening Global Presence in ARV Market

The Anti-Retroviral API segment is a critical therapeutic area with a strong international demand, especially in low- and middle-income countries where public health programs are supported by global institutions.

By securing WHO prequalification for its Vizag plant, SMS Pharma becomes a more attractive and eligible partner for international buyers, allowing it to expand exports to countries in Africa, Asia, and Latin America. This also boosts the company’s competitiveness against larger global pharma players.

Leadership’s Perspective on the Approval

Mr. P. Vamsi Krishna, Executive Director at SMS Pharmaceuticals, expressed pride over the development. He stated:

“The WHO Geneva prequalification reflects the company’s strong compliance with stringent international regulatory standards, reinforcing its reputation for quality, reliability, and global competitiveness.”

This statement echoes the company’s long-term vision of becoming a globally trusted supplier of APIs and pharmaceutical intermediates, with an emphasis on sustainability, quality assurance, and patient safety.

Strategic Significance for SMS Pharmaceuticals

The WHO approval is not just a feather in the cap for SMS Pharma—it is a strategic leap forward. It:

• Elevates the company's brand value among regulatory bodies and international buyers.

• Enables faster access to tenders and procurement programs run by WHO and its partners.

• Supports the company’s long-term growth trajectory in regulated and semi-regulated global markets.

As more governments and organisations rely on WHO-prequalified manufacturers for sourcing critical health products, SMS Pharma now stands in a stronger position to bid for international contracts, especially those concerning HIV/AIDS treatment programs.

A Boost for India’s Pharma Export Landscape

India is known as the "Pharmacy of the World", and companies like SMS Pharmaceuticals are key contributors to this global identity. The WHO Geneva nod for the Vizag facility:

• Reinforces India’s role in supplying affordable and high-quality generic medicines globally.

• Enhances trust in Indian API manufacturers among buyers in emerging markets.

• Encourages other Indian pharma firms to pursue higher regulatory compliance and global certifications.

This achievement contributes not just to the company's portfolio but also strengthens India's footprint in global public health initiatives.

Looking Ahead: New Avenues for SMS Pharmaceuticals

With this approval in hand, SMS Pharma is expected to:

• Scale up production at the Vizag facility to meet growing global demand.

• Enter new export markets that require WHO prequalification as a prerequisite.

• Attract more partnerships and long-term supply agreements with NGOs and government agencies.

• Invest in further compliance and upgrades across other facilities to replicate this success.

This milestone positions SMS Pharma as a globally recognised API manufacturer and sets the stage for long-term expansion and revenue diversification through international collaborations.

Conclusion

The WHO Geneva prequalification of SMS Pharmaceuticals’ Vizag facility is a transformational milestone. It not only validates the company’s commitment to global quality standards, but also enhances its strategic positioning in the international pharmaceutical supply chain—especially in the ARV API segment.

By meeting the WHO’s rigorous requirements, SMS Pharma has ensured it remains a trusted name in the global healthcare ecosystem, capable of supporting critical therapeutic areas with safe, effective, and affordable APIs.

This development reflects the growing influence of Indian pharmaceutical manufacturers on the world stage and reaffirms the country's role as a pillar of global public health.

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