Simpex Pharma Private Limited

Simpex Pharma Private Limited, established on March 7, 1997, is a privately held pharmaceutical company headquartered in New Delhi, India. The company is registered under the Corporate Identification Number (CIN) U33112DL1997PTC085657 and is classified as a private limited company. It has an authorized and paid-up capital of ₹2.50 crore.

The company's registered office is located at Flat No-302, 3rd Floor, Ansal Tower, 38, New Delhi, Delhi, 110019. Simpex Pharma specializes in the manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, focusing on therapeutic areas such as tuberculosis and advanced antibiotics. The company has a workforce of approximately 157 employees.

Simpex Pharma operates a state-of-the-art manufacturing facility located in the foothills of the Himalayas, near Kotdwar in Uttarakhand, approximately 235 kilometers from New Delhi. This facility spans 16,000 square meters and is designed to comply with global Good Manufacturing Practice (GMP) standards. The plant specializes in the production of solid oral dosage forms, including tablets and capsules. It is equipped with modern equipment and adheres to stringent quality control measures to ensure the production of high-quality pharmaceutical products.

The leadership team at Simpex Pharma Private Limited comprises:

• Naresh Santhanam: Director since February 15, 2010.
• Ajay Kumar Mishra: Director since April 6, 2010.
• Piyush Kumar Singh: Director since January 2, 2020.

These individuals bring a wealth of experience and expertise to the company's strategic direction and operations.

Simpex Pharma Private Limited has made significant strides in expanding its presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facility in Uttarakhand is WHO-GMP approved, which is a critical requirement for market access in these regions. This certification indicates that the facility adheres to international standards of quality and safety, facilitating the export of pharmaceutical products to these markets.

In addition to its presence in regulated markets, Simpex Pharma has been actively exploring opportunities in emerging markets across Africa, Latin America, and Southeast Asia. The WHO-GMP certification of its manufacturing facility enhances the company's ability to meet the regulatory requirements of these regions, thereby facilitating market entry and expansion. This strategic focus aligns with the company's objective to diversify its market presence and tap into the growing demand for pharmaceutical products in these regions.

Simpex Pharma's geographic strategy demonstrates a balanced approach between established and emerging markets. The company's strong foothold in regulated markets, supported by its WHO-GMP certified manufacturing facility, mitigates risks associated with market entry and compliance. Simultaneously, its proactive engagement in emerging markets positions the company to capitalize on growth opportunities and diversify its revenue streams. This strategic diversification helps in reducing dependence on a single market and spreads potential risks.

As of March 2026, specific details regarding Simpex Pharma's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available. The company's WHO-GMP certification of its manufacturing facility suggests a commitment to meeting international quality standards, which is a prerequisite for FDA approvals. However, without explicit information on FDA-related filings and approvals, a comprehensive assessment of the company's FDA status cannot be provided at this time.

Simpex Pharma's manufacturing facility in Uttarakhand holds WHO-GMP certification, indicating compliance with international standards for pharmaceutical manufacturing. This certification is essential for exporting products to various international markets, including the European Union. While the WHO-GMP certification is a significant step towards meeting EU GMP requirements, obtaining EU GMP certification would further enhance the company's credibility and market access within the European Union. As of March 2026, specific details regarding EU GMP certification are not publicly available.

Simpex Pharma Private Limited operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility in Uttarakhand is WHO-GMP certified, which aligns with CDSCO's standards for pharmaceutical manufacturing. This certification facilitates the company's compliance with both national and international regulatory requirements, ensuring the production of safe and effective pharmaceutical products.

As of March 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Simpex Pharma Private Limited. The absence of such regulatory actions suggests that the company maintains a strong compliance record with regulatory authorities. However, without access to detailed inspection histories and regulatory correspondence, a comprehensive assessment cannot be provided.

Simpex Pharma Private Limited operates in a competitive pharmaceutical industry, with several key players in the tuberculosis medications and advanced antibiotics segments. While specific market share data is not publicly available, the company's focus on high-quality manufacturing and adherence to international standards positions it favorably in the market. The WHO-GMP certification of its manufacturing facility further enhances its competitive edge by ensuring product quality and safety.

Simpex Pharma's key differentiators include its WHO-GMP certified manufacturing facility, which ensures compliance with international quality standards, and its focus on research and innovation, leading to the development of over 150 products with an additional 50 in the pipeline. These strengths enable the company to address challenging therapeutic needs and maintain a competitive edge in the pharmaceutical industry.

Simpex Pharma Private Limited's current strategic direction emphasizes the production of high-quality pharmaceutical formulations, with a focus on therapeutic areas such as tuberculosis and advanced antibiotics. The company's WHO-GMP certified manufacturing facility supports this strategy by ensuring compliance with international standards. Looking ahead, the company aims to expand its product portfolio and market presence, leveraging its manufacturing capabilities and commitment to quality to meet the evolving needs of the global pharmaceutical market.

Simpex Pharma Private Limited demonstrates a strong track record in pharmaceutical manufacturing, with a focus on high-quality finished formulations. The company's WHO-GMP certified manufacturing facility indicates a commitment to international quality standards. While specific export volumes and consistency metrics are not publicly available, the company's strategic focus on regulated and emerging markets suggests a reliable and consistent supply chain.

Importers should verify the following certifications to ensure product quality and regulatory compliance:

• WHO-GMP Certification: Confirms adherence to international manufacturing standards.
• EU GMP Certification: Validates compliance with European Union manufacturing standards.
• FDA Facility Registration: Indicates eligibility for exporting to the United States.

These certifications can typically be verified through the respective regulatory bodies' official websites or by requesting copies directly from the manufacturer.

Importers should undertake the following steps to ensure a thorough evaluation of Simpex Pharma Private Limited:

• Verify Certifications: Confirm WHO-GMP, EU GMP, and FDA certifications.
• Assess Manufacturing Facility: Evaluate the facility's compliance with international standards.
• Review Regulatory Compliance: Check for any regulatory actions or violations.
• Evaluate Financial Stability: Analyze financial statements for profitability and solvency.
• Assess Product Portfolio: Review the range and quality of products offered.

Red flags to watch for include discrepancies in certification documents, unresolved regulatory issues, and financial instability. Recommended pre-order checks involve obtaining and verifying all relevant certifications and conducting a comprehensive audit of the company's operations and financial health.