Renown Pharmaceuticals Private Limited

Renown Pharmaceuticals Private Limited, established on September 5, 2005, is a private limited company headquartered in Vadodara, Gujarat, India. The company is registered under the Corporate Identification Number (CIN) U24230GJ2005PTC046714. It operates in the pharmaceutical sector, focusing on the manufacture of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The authorized share capital stands at ₹21.50 crore, with a paid-up capital of ₹16.50 crore. As of December 18, 2025, Renown Pharmaceuticals employed approximately 71 professionals.

Renown Pharmaceuticals operates a state-of-the-art manufacturing facility in Vadodara, Gujarat. The plant is equipped with three encapsulation lines and has provisions for five additional lines, indicating a capacity to scale operations as needed. The facility adheres to international standards, including WHO-GMP and ISO certifications, ensuring the production of high-quality pharmaceutical products.

The leadership team at Renown Pharmaceuticals comprises:

• Ramesh Kumar Jatia: Managing Director, appointed on December 31, 2009.

• Smita Jatia Rameshkumar: Director, appointed on September 5, 2005.

• Atishay Jatia Ramesh: Director, appointed on September 28, 2007.

• Satish Bangera Duggappa: Director, appointed on December 31, 2009.

Additionally, Scany Prabhudas Parmar serves as the Company Secretary, appointed on October 1, 2022.

Renown Pharmaceuticals has made significant strides in regulated markets, particularly in the United States, European Union, United Kingdom, and Australia. The company's manufacturing facility is designed to meet the stringent requirements of regulatory bodies such as the MHRA (UK), TGA (Australia), and WHO-GMP, facilitating market access in these regions. Renown Pharmaceuticals has expressed intentions to enter the US OTC and TGA segments in the near future, indicating a proactive approach to expanding its global footprint.

Renown Pharmaceuticals has also focused on penetrating emerging markets in Africa, Latin America, and Southeast Asia. The company's adherence to WHO-GMP standards enhances its credibility and facilitates access to these markets. By ensuring compliance with international quality standards, Renown Pharmaceuticals positions itself as a reliable supplier in these regions.

Renown Pharmaceuticals demonstrates a diversified geographic strategy by targeting both regulated and emerging markets. This approach mitigates concentration risk and leverages growth opportunities across different regions. The company's commitment to adhering to international quality standards, such as WHO-GMP and ISO certifications, supports its strategic direction and enhances its competitive position globally.

As of March 28, 2026, specific details regarding Renown Pharmaceuticals' FDA facility registrations, approved ANDAs, DMF filings, and inspection history are not publicly available. The company's focus on WHO-GMP and ISO certifications suggests a commitment to meeting international quality standards, which is a prerequisite for FDA approvals. However, without explicit FDA approvals or registrations, the company's products may face challenges entering the U.S. market.

Renown Pharmaceuticals' manufacturing facility is designed to meet WHO-GMP and EU GMP standards, ensuring the production of high-quality pharmaceutical products. These certifications are crucial for market access in various international markets, including the European Union and other regions that recognize WHO-GMP standards. The company's adherence to these standards underscores its commitment to quality and regulatory compliance.

Renown Pharmaceuticals holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company's compliance with CDSCO regulations ensures that its products meet the required quality and safety standards for both domestic and international markets. Additionally, Renown Pharmaceuticals has obtained state drug controller approvals and export No Objection Certificates (NOCs), facilitating its export activities.

As of March 28, 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Renown Pharmaceuticals. The company's adherence to international quality standards, such as WHO-GMP and ISO certifications, suggests a proactive approach to regulatory compliance. However, the absence of specific regulatory action records does not guarantee the absence of such actions, and further due diligence is recommended.

Renown Pharmaceuticals operates in a competitive landscape with several key players in the pharmaceutical manufacturing sector. While specific competitors are not identified in the available data, the company's focus on high-quality manufacturing, adherence to international standards, and strategic geographic diversification position it favorably in the market. Renown Pharmaceuticals' commitment to quality and regulatory compliance enhances its competitiveness in both regulated and emerging markets.

Renown Pharmaceuticals' key differentiators include its state-of-the-art manufacturing facility designed to meet WHO-GMP and ISO standards, a diversified product portfolio encompassing nutritional supplements and Ayurvedic & herbal products, and a strategic focus on both regulated and emerging markets. These factors collectively enhance the company's competitive advantage and market positioning.

Renown Pharmaceuticals is strategically positioned as a contract manufacturer specializing in soft gelatin capsules, catering to both pharmaceutical and nutraceutical sectors. The company's adherence to international quality standards, such as WHO-GMP and ISO certifications, supports its strategic direction and enhances its appeal to global clients. Looking ahead, Renown Pharmaceuticals aims to expand its presence in regulated markets, including the U.S. OTC and TGA segments, while continuing to serve emerging markets.

Renown Pharmaceuticals has demonstrated a consistent track record in pharmaceutical manufacturing, with a total export value of $1.8 million USD and 103 shipments across 2 therapeutic categories. The company's portfolio concentration is notable, with its top 5 products accounting for 100% of exports. This focus on a select range of products indicates a strategic approach to market positioning and resource allocation. The company's adherence to international quality standards, such as WHO-GMP and ISO certifications, further underscores its reliability as a supplier.

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

• WHO-GMP Certification: Indicates adherence to World Health Organization Good Manufacturing Practices. Verification can be done through the WHO website or by contacting the company directly.

• EU GMP Certification: Demonstrates compliance with European Union Good Manufacturing Practices. Verification can be conducted through the European Medicines Agency (EMA) or by reaching out to the company.

• ISO Certification: Reflects adherence to international quality management standards. Verification can be performed through the International Organization for Standardization (ISO) or by contacting the company.

Importers should undertake the following steps to ensure due diligence:

• Verify Certifications: Confirm the validity of WHO-GMP, EU GMP, and ISO certifications through the respective certifying bodies.

• Assess Regulatory Compliance: Review the company's compliance with CDSCO regulations and obtain necessary export NOCs.

• Evaluate Financial Health: Analyze the company's financial statements to assess stability and profitability.

• Inspect Manufacturing Facilities: Conduct site visits to evaluate manufacturing practices and quality control measures.

• Review Product Portfolio: Examine the product range to ensure alignment with market needs and quality standards.

Red flags to watch for include expired or invalid certifications, unresolved regulatory issues, financial instability, and discrepancies in product quality.