Inventia Healthcare Limited

Inventia Healthcare Limited, established on September 27, 1985, is a privately held pharmaceutical development and manufacturing company headquartered in Mumbai, Maharashtra, India. The company's Corporate Identification Number (CIN) is U24239MH1985PLC037597. As of August 7, 2025, Inventia Healthcare reported an annual revenue of $89.42 million USD, with a net profit of $6.04 million USD for the fiscal year ending March 31, 2024. The company employs approximately 962 individuals, reflecting its substantial presence in the pharmaceutical sector. In August 2024, Platinum Equity acquired a controlling stake in Inventia Healthcare, indicating a strategic move to enhance the company's growth and market reach.

Inventia Healthcare operates a state-of-the-art manufacturing facility located in Ambernath, Maharashtra, India. This facility specializes in the production of oral solid dosage (OSD) forms, including tablets and capsules, catering to both regular and value-added generics. The manufacturing platform is accredited by stringent regulatory authorities such as the U.S. FDA and the U.K. MHRA, ensuring compliance with international quality standards. Additionally, the company maintains a research and development center in Thane, Maharashtra, focusing on the development of complex generic and novel pharmaceutical products.

The leadership team at Inventia Healthcare is headed by Co-Founder, Chairman, and Managing Director Janak Shah, who has been instrumental in the company's growth and strategic direction. Naresh Shah serves as the Chief Operating Officer, overseeing the company's operational activities. In August 2024, Platinum Equity acquired a controlling stake in Inventia Healthcare, indicating a strategic move to enhance the company's growth and market reach.

Inventia Healthcare has established a significant presence in regulated markets, including the United States, European Union, United Kingdom, and Australia. The company's manufacturing facility in Ambernath is accredited by the U.S. FDA and the U.K. MHRA, ensuring compliance with stringent regulatory standards. This accreditation facilitates the company's ability to supply pharmaceutical products to these markets. Additionally, Inventia Healthcare has been involved in filing Abbreviated New Drug Applications (ANDAs) with the U.S. FDA, indicating its commitment to expanding its product portfolio in the U.S. market.

Inventia Healthcare has expanded its reach to emerging markets, including Africa, Latin America, and Southeast Asia. The company's manufacturing facility holds various regulatory approvals, such as those from the U.S. FDA, U.K. MHRA, KFDA, ANVISA, INVIMA, COFEPRIS, and others, enabling access to these regions. This global footprint allows Inventia Healthcare to cater to a diverse customer base and meet the pharmaceutical needs of various emerging markets.

Inventia Healthcare's geographic strategy demonstrates a balanced approach, with a significant focus on both regulated and emerging markets. The company's manufacturing facility's accreditations by the U.S. FDA and the U.K. MHRA underscore its commitment to meeting international quality standards, facilitating access to developed markets. Simultaneously, the company's expansion into emerging markets, supported by various regulatory approvals, indicates a strategic diversification to mitigate concentration risk and capitalize on growth opportunities in these regions.

Inventia Healthcare's manufacturing facility in Ambernath, Maharashtra, India, is accredited by the U.S. FDA, ensuring compliance with stringent regulatory standards. This accreditation facilitates the company's ability to supply pharmaceutical products to the U.S. market. Additionally, Inventia Healthcare has been involved in filing Abbreviated New Drug Applications (ANDAs) with the U.S. FDA, indicating its commitment to expanding its product portfolio in the U.S. market.

Inventia Healthcare's manufacturing facility holds various regulatory approvals, including those from the U.S. FDA and the U.K. MHRA. While specific details regarding WHO prequalification and EU GMP certificates are not explicitly mentioned in the available sources, the company's adherence to international quality standards suggests a commitment to meeting global regulatory requirements.

Inventia Healthcare operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility in Ambernath is accredited by the U.S. FDA and the U.K. MHRA, indicating compliance with international standards. Specific details regarding CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not explicitly mentioned in the available sources.

As of March 28, 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to Inventia Healthcare by regulatory authorities. This absence suggests that the company maintains a strong compliance record with regulatory standards.

Inventia Healthcare operates in a competitive landscape, supplying both semi-finished and finished oral solid dosage (OSD) formulations for regular and value-added generics. The company's partners include global and leading local pharmaceutical companies that sell in more than 40 countries across North America, South America, Europe, Southeast Asia, the Middle East, and Africa. While specific market share data is not available, Inventia Healthcare's extensive global reach and regulatory accreditations position it as a significant player in the pharmaceutical manufacturing sector.

Inventia Healthcare's key differentiators include its state-of-the-art manufacturing facility in Ambernath, Maharashtra, which is accredited by the U.S. FDA and the U.K. MHRA, ensuring compliance with stringent regulatory standards. The company's focus on developing complex generic and novel pharmaceutical products enhances its product portfolio and supports patient compliance and comfort. Additionally, Inventia Healthcare's expansion into over 50 countries globally demonstrates its ability to cater to diverse markets and meet various pharmaceutical needs.

Inventia Healthcare's current strategic direction focuses on the development and manufacturing of complex generic and novel pharmaceutical products, with an emphasis on oral solid dosage forms. The company's partnerships with global and local pharmaceutical companies across more than 40 countries highlight its commitment to expanding its reach in both emerging and regulated markets. Looking ahead, Inventia Healthcare is well-positioned to leverage its manufacturing capabilities and regulatory accreditations to further enhance its market presence and continue delivering high-quality pharmaceutical products.

Inventia Healthcare has demonstrated a strong track record in pharmaceutical manufacturing, with a total export value of $36.5 million USD and 1,098 shipments across 11 products in 2022-2026. The company's portfolio concentration, with the top five products accounting for 85.7% of exports, indicates a focused approach to product development and market penetration. The absence of publicly available records indicating any Form 483 observations, warning letters, or import alerts suggests a reliable and compliant manufacturing process. These factors collectively position Inventia Healthcare as a dependable supplier in the pharmaceutical industry.

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

• FDA Approval: Confirm that the manufacturing facility is registered with the U.S. FDA. This can be verified through the FDA's official website or by contacting the FDA directly.

• WHO-GMP Certification: Check for World Health Organization Good Manufacturing Practice certification. Verification can be done by consulting the WHO's official website or contacting the organization.

• EU GMP Certification: Ensure that the manufacturing facility holds European Union Good Manufacturing Practice certification. This can be verified through the European Medicines Agency (EMA) or the relevant national regulatory authority.

• ISO Certification: Verify ISO certifications related to quality management systems. This information is typically available on the company's official website or can be obtained by contacting the company directly.

When conducting due diligence on Inventia Healthcare Limited, consider the following steps:

• Regulatory Compliance