Prime Pharmaceuticals Private Limited

Prime Pharmaceuticals Private Limited, established on September 11, 1995, is a privately held Indian pharmaceutical company headquartered in Mumbai, Maharashtra. The company is registered under the Corporate Identification Number (CIN) U24231MH1995PTC092543. As of the latest available data, Prime Pharmaceuticals has an authorized capital of ₹20 million and a paid-up capital of ₹6.318 million. The company operates in the manufacturing of chemical substances used in pharmaceuticals, including antibiotics, endocrine products, basic vitamins, and other related products.

The registered office is located at 601, 6th Floor, Kamla Executive Park, A K Road, Andheri East, Mumbai, Maharashtra 400059, India. Prime Pharmaceuticals has a global presence, exporting to over 50 countries, and is committed to delivering high-quality, cost-effective healthcare solutions.

Prime Pharmaceuticals operates state-of-the-art manufacturing facilities in India, adhering to stringent quality standards. The company specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. These facilities are equipped with advanced technology to ensure the production of high-quality products. While specific details regarding plant locations and capacities are not publicly disclosed, the company's commitment to quality is evident through its adherence to global regulatory standards.

The leadership team at Prime Pharmaceuticals Private Limited comprises experienced professionals dedicated to the company's growth and success. Key executives include:

• Ashish Anil Vora: Director since September 11, 1995.

• Devang Subodh Thakar: Director since April 2, 1998.

• Manish Patel: Director since April 2, 1998.

• Manish Navnitrai Vora: Director since May 23, 2024.

• Ramamurthy Ayyavuthevar: Director since February 5, 2021.

• Irfan Vazirally: Director since May 20, 2022.

The leadership team's extensive experience in the pharmaceutical industry contributes to the company's strategic direction and operational excellence.

Prime Pharmaceuticals Private Limited has established a significant presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has filed numerous dossiers annually, indicating a robust pipeline of regulatory submissions. While specific details regarding regulatory approvals in these markets are not publicly disclosed, the company's participation in international exhibitions, such as iPHEX India 2025, underscores its commitment to global market expansion and compliance with international standards.

Prime Pharmaceuticals has strategically expanded its footprint in emerging markets across Africa, Latin America, and Southeast Asia. The appointment of Ms. Amrita Bhat as Vice President – Sales, Marketing, and Business Development for the Africa Region in October 2025 highlights the company's focus on these regions. Ms. Bhat's extensive experience in the African market is expected to drive growth and enhance access to healthcare in these emerging markets.

Prime Pharmaceuticals demonstrates a diversified geographic strategy by exporting to over 50 countries, including both developed and emerging markets. This approach mitigates concentration risk and positions the company to leverage growth opportunities across various regions. The strategic direction emphasizes expanding market reach while maintaining a strong presence in established markets.

Specific details regarding Prime Pharmaceuticals' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available. However, the company's participation in international exhibitions and its global export activities suggest a commitment to meeting international regulatory standards.

While specific certifications such as WHO prequalification and EU Good Manufacturing Practice (GMP) certificates are not publicly disclosed, Prime Pharmaceuticals' adherence to global regulatory standards is evident through its extensive export activities and participation in international exhibitions. The company's commitment to quality and compliance underscores its dedication to meeting international manufacturing standards.

Prime Pharmaceuticals holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company's compliance with Indian regulatory standards is further demonstrated by its active status and adherence to the Companies Act, as indicated by its Corporate Identification Number (CIN) U24231MH1995PTC092543.

As of March 28, 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Prime Pharmaceuticals Private Limited. The company's active participation in international exhibitions and its global export activities suggest a proactive approach to regulatory compliance.

Prime Pharmaceuticals operates in a competitive landscape with numerous pharmaceutical companies offering similar products. While specific market share data is not publicly available, the company's diverse product portfolio and global export activities position it as a significant player in the pharmaceutical industry. The company's focus on quality, innovation, and customer-centric approaches contributes to its competitive edge.

Prime Pharmaceuticals' key differentiators include its commitment to quality, innovation, and customer-centric approaches. The company's extensive export activities and participation in international exhibitions highlight its global reach and dedication to meeting international standards. These factors contribute to its competitive advantages in the pharmaceutical industry.

Prime Pharmaceuticals' strategic direction focuses on expanding its global footprint through exports to over 50 countries, including both developed and emerging markets. The company's participation in international exhibitions and the appointment of experienced leaders for regional markets underscore its commitment to growth and market diversification. The future outlook appears positive, with a focus on innovation, quality, and customer satisfaction driving the company's strategic initiatives.

Prime Pharmaceuticals demonstrates a strong track record in the pharmaceutical industry, with over 30 years of experience. The company's export volume and consistency are evident through its presence in over 50 countries and participation in international exhibitions. Reliability indicators include adherence to global regulatory standards and a commitment to quality, as reflected in its product offerings and customer-centric approach.

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

• FDA Registration: Confirm the company's FDA facility registration status through the FDA's official website.

• WHO-GMP Certification: Verify WHO Good Manufacturing Practice certification through the World Health Organization's official channels.

• EU GMP Certification: Check for EU Good Manufacturing Practice certification via the European Medicines Agency's official resources.

• ISO Certification: Ensure ISO certification by reviewing the company's ISO certification documents or contacting the International Organization for Standardization.

Importers should undertake the following verification steps:

• Regulatory Compliance: Confirm the company's compliance with relevant regulatory bodies such as the FDA, WHO, and EU authorities.

• Quality Assurance: Review the company's quality assurance processes and certifications to ensure product quality.

• Financial Stability: Assess the company's financial health through available financial statements and credit reports.

• Supply Chain Reliability: Evaluate the company's supply chain processes and history of timely deliveries.

Red flags to watch for include discrepancies in regulatory certifications, negative financial indicators, and a history of compliance issues. Recommended pre-order checks involve verifying product samples, reviewing contractual terms, and assessing the company's customer service responsiveness.