Niya Healthcare Private Limited

Niya Healthcare Private Limited, established on April 12, 2006, is a private unlisted company headquartered in Satara, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U85100PN2006PTC022320. Its authorized and paid-up capital stands at ₹100,000 each. The registered office is located at Plot No.36 S No. 19B/20B, Tulasi Vihar Visawa Park, Godoli, Satara, Maharashtra, 415002.

Niya Healthcare specializes in the manufacturing and export of pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company has a significant presence in the global pharmaceutical market, with exports totaling $1.7 million USD across 83 shipments from 2022 to 2026. Its product portfolio is concentrated in two therapeutic categories: Respiratory & OTC (85.6%) and Advanced Antibiotics (14.4%). The top five products, including Phenylephrine and Secnidazole, account for 100% of the company's export value.

Niya Healthcare operates manufacturing facilities in Satara, Maharashtra, India. The company specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. While specific details regarding plant capacities and certifications are not publicly disclosed, Niya Healthcare emphasizes its compliance with global regulatory standards, including EU GMP, WHO-GMP, USFDA, and ISO-9001. (nhpl.co)

The leadership team at Niya Healthcare Private Limited comprises:

• Yatin Narayandas Doshi: Director
• Mohini Narayandas Doshi: Director
• Supriya Yatin Doshi: Director

All three directors have been with the company since its inception on April 12, 2006.

Niya Healthcare Private Limited has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has registered its products in various countries across Europe, Africa, Asia, Central and South America, and the Commonwealth of Independent States (CIS). Niya Healthcare's compliance with global regulatory agencies such as EU GMP, WHO-GMP, USFDA, and ISO-9001 underscores its commitment to meeting international standards. (nhpl.co)

Niya Healthcare Private Limited has expanded its reach into emerging markets, including regions in Africa, Latin America, and Southeast Asia. The company's adherence to WHO prequalification and EU GMP certifications facilitates access to these markets, enabling it to meet the regulatory requirements necessary for product registration and distribution. (nhpl.co)

Niya Healthcare's export strategy demonstrates a strong focus on the Respiratory & OTC therapeutic category, which constitutes 85.6% of its export value. This concentration indicates a strategic emphasis on a specific market segment. The company's expansion into diverse geographic regions, including regulated and emerging markets, reflects a deliberate approach to mitigate concentration risk and leverage growth opportunities across various global markets.

Specific details regarding Niya Healthcare's 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 compliance with global regulatory standards, including USFDA, suggests adherence to FDA requirements. (nhpl.co)

Niya Healthcare Private Limited holds certifications from the World Health Organization's Good Manufacturing Practice (WHO-GMP) and the European Union's Good Manufacturing Practice (EU GMP). These certifications affirm the company's commitment to maintaining high-quality manufacturing standards and facilitate access to international markets that require such compliance. (nhpl.co)

Niya Healthcare Private Limited operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company holds manufacturing licenses and approvals from state drug controllers, ensuring compliance with Indian pharmaceutical regulations. Additionally, Niya Healthcare has obtained export No Objection Certificates (NOCs), enabling it to export pharmaceutical products to various international markets. (nhpl.co)

As of March 28, 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to Niya Healthcare Private Limited. The company's adherence to global regulatory standards, including EU GMP, WHO-GMP, USFDA, and ISO-9001, suggests a proactive approach to compliance and quality assurance. (nhpl.co)

In the pharmaceutical export sector, Niya Healthcare Private Limited faces competition from both domestic and international companies. While specific competitors in overlapping categories are not publicly disclosed, Niya Healthcare's focus on the Respiratory & OTC therapeutic category positions it in a competitive market segment. The company's compliance with global regulatory standards, including EU GMP, WHO-GMP, USFDA, and ISO-9001, provides a competitive edge in meeting international market requirements. (nhpl.co)

Niya Healthcare's key differentiators include its specialized focus on the Respiratory & OTC therapeutic category, accounting for 85.6% of its export value. The company's adherence to global regulatory standards, such as EU GMP, WHO-GMP, USFDA, and ISO-9001, underscores its commitment to quality and compliance. Additionally, Niya Healthcare's strategic expansion into diverse geographic regions, including regulated and emerging markets, enhances its global presence and market reach. (nhpl.co)

Niya Healthcare Private Limited's current strategic direction focuses on the export of finished pharmaceutical formulations, with a particular emphasis on the Respiratory & OTC therapeutic category. The company's adherence to global regulatory standards and its expansion into diverse geographic regions reflect a strategy aimed at mitigating concentration risk and leveraging growth opportunities across various international markets. Looking ahead, Niya Healthcare is well-positioned to continue its growth trajectory by capitalizing on its strengths in quality manufacturing and regulatory compliance. (nhpl.co)

Niya Healthcare Private Limited has demonstrated a consistent track record in pharmaceutical exports, with a total export value of $1.7 million USD across 83 shipments from 2022 to 2026. The company's portfolio is concentrated in two therapeutic categories: Respiratory & OTC (85.6%) and Advanced Antibiotics (14.4%). The top five products, including Phenylephrine and Secnidazole, account for 100% of the company's export value. This concentration indicates a focused approach to product offerings. The company's adherence to global regulatory standards, such as EU GMP, WHO-GMP, USFDA, and ISO-9001, underscores its commitment to quality and compliance, enhancing its reliability as a supplier. (nhpl.co)

Importers should verify the following certifications when considering Niya Healthcare Private Limited as a supplier:

• FDA Registration: Confirm the company's registration status with the U.S. Food and Drug Administration (FDA) to ensure compliance with U.S. regulations.

• WHO-GMP Certification: Verify the World Health Organization's Good Manufacturing Practice certification to ensure adherence to international manufacturing standards.

• EU GMP Certification: Check the European Union's Good Manufacturing Practice certification to confirm compliance with European manufacturing standards.

• ISO-9001 Certification: Ensure the company holds ISO-9001 certification, indicating a commitment to quality management systems.

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

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

• Verify Regulatory Certifications: Confirm the validity of FDA, WHO-GMP, EU GMP, and ISO-9001 certifications.

• Assess Financial Health: Review the company's financial statements for the latest fiscal year to evaluate profitability and financial stability.

• Evaluate Product Portfolio: Analyze the concentration of the product portfolio to assess potential risks associated with reliance on a limited number of products.

• Review Export Records: Examine export volumes and consistency to gauge the company's reliability and experience in international markets.

• Inspect Manufacturing Facilities: If possible, conduct site visits to assess manufacturing capabilities and compliance with quality