Niba Healthcare

Niba Healthcare, established in 2018, is a sole proprietorship based in Nagpur, Maharashtra, India. The company specializes in manufacturing, exporting, and trading a diverse range of pharmaceutical products, including tablets, capsules, syrups, and injections. Under the leadership of Mr. Nishant Barethiya, Niba Healthcare has developed a reputation for delivering high-quality pharmaceutical formulations.

The company operates with an annual turnover ranging between ₹5 to ₹25 crore and employs a team of 11 to 25 individuals. Niba Healthcare is registered under the Goods and Services Tax (GST) with the number 27BFAPB0168Q1ZD and holds an Import Export Code (IEC) of BFAPB0168Q.

Niba Healthcare's manufacturing facility is located in Nagpur, Maharashtra. The plant is equipped to produce a variety of pharmaceutical formulations, including tablets, capsules, syrups, and injections. While specific production capacities and specializations are not publicly disclosed, the facility adheres to stringent quality standards, as evidenced by its ISO 9001:2015 certification.

Mr. Nishant Barethiya serves as the Proprietor of Niba Healthcare. His leadership has been instrumental in the company's growth and its commitment to delivering quality pharmaceutical products. Under his guidance, Niba Healthcare has established itself as a reliable exporter in the pharmaceutical industry.

Niba Healthcare has made significant strides in exporting its pharmaceutical products to various international markets, including Korea, Saudi Arabia, the United Kingdom, Tanzania, and Kenya. The company's adherence to global quality standards, such as ISO 9001:2015 and WHO-GMP certifications, facilitates its entry into these regulated markets. However, specific details regarding regulatory filings, approvals, and market access status in the US, EU, UK, Australia, and Japan are not publicly available.

Niba Healthcare's export activities extend to regions in Africa, Latin America, and Southeast Asia, with notable shipments to countries like Tanzania and Kenya. The company's WHO-GMP certification enhances its credibility and facilitates access to these emerging markets. However, specific details regarding WHO prequalification and its impact on market access are not publicly disclosed.

Niba Healthcare's export strategy demonstrates a focus on both established and emerging markets, with shipments to regions such as Korea, Saudi Arabia, the United Kingdom, Tanzania, and Kenya. This diversified approach helps mitigate concentration risk and positions the company to leverage growth opportunities across different geographies. The strategic direction appears to be geared towards expanding its global footprint while maintaining a strong presence in key markets.

Specific information regarding Niba Healthcare's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history is not publicly available. The company's export activities to various international markets suggest compliance with global regulatory standards, but detailed FDA-related information is not disclosed.

Niba Healthcare holds WHO-GMP certification, indicating adherence to the World Health Organization's Good Manufacturing Practices. This certification underscores the company's commitment to maintaining high-quality manufacturing standards. However, specific details regarding EU GMP certificates and EDQM status are not publicly available.

Niba Healthcare operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company holds the necessary manufacturing licenses and approvals from state drug controllers, ensuring compliance with Indian pharmaceutical regulations. Specific details regarding export No Objection Certificates (NOCs) are not publicly disclosed.

As of March 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Niba Healthcare. The company's adherence to quality standards and regulatory compliance suggests a proactive approach to maintaining its manufacturing practices.

Niba Healthcare operates in a competitive pharmaceutical export market, with key competitors in overlapping categories such as lipid & metabolism, antimalarial & antiparasitic, and biologics & immunotherapy. While specific market share comparisons are not publicly available, Niba Healthcare's focus on high-quality formulations and adherence to international standards position it as a competitive player in these therapeutic areas.

Niba Healthcare's commitment to quality is demonstrated through its ISO 9001:2015 and WHO-GMP certifications. The company's diverse product portfolio, including pharmaceutical injections, anticancer medicines, and anti-HIV drugs, caters to a wide range of therapeutic needs. Additionally, Niba Healthcare's strategic export activities to various international markets highlight its global reach and adaptability.

Niba Healthcare's current strategic direction focuses on manufacturing and exporting finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company's adherence to international quality standards and its diverse product portfolio position it well for future growth in both established and emerging markets. While specific plans regarding generics, specialty drugs, biosimilars, or Contract Development and Manufacturing Organization (CDMO) services are not publicly disclosed, Niba Healthcare's commitment to quality and regulatory compliance suggests a strong foundation for strategic expansion.

Niba Healthcare has demonstrated a consistent track record in exporting pharmaceutical products, with a total export value of $86,000 USD across 65 shipments. The company's adherence to quality standards, as evidenced by its ISO 9001:2015 and WHO-GMP certifications, indicates a reliable manufacturing process. The diverse product portfolio and strategic export activities suggest a commitment to meeting global pharmaceutical demands.

Importers should verify the following certifications when considering Niba Healthcare as a supplier:

• FDA Registration: Confirm the company's FDA facility registration status to ensure compliance with U.S. regulatory standards.

• WHO-GMP Certification: Verify the WHO-GMP certification to ensure adherence to international manufacturing practices.

• EU GMP Certification: Check for EU GMP certification to confirm compliance with European manufacturing standards.

• ISO 9001:2015 Certification: Ensure the company holds ISO 9001:2015 certification, indicating a commitment to quality management systems.

These certifications can typically be verified through the issuing organizations' official websites or by contacting Niba Healthcare directly.

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

• Verify Certifications: Confirm the validity of FDA, WHO-GMP, EU GMP, and ISO 9001:2015 certifications.

• Assess Regulatory Compliance: Review the company's compliance with CDSCO and other relevant regulatory bodies.

• Evaluate Product Quality: Request product samples and review quality control documentation.

• Review Financial Stability: Analyze financial statements to assess the company's economic health.

• Check Export Records: Examine export history and customer feedback to gauge reliability.

Be cautious of any discrepancies in certification details or unexplained gaps in regulatory approvals. Ensure all communications are conducted through official channels to avoid potential fraud.