GNH India Pharmaceuticals Limited

GNH India Pharmaceuticals Limited, established on May 11, 2018, is a public limited company headquartered in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U51909MH2018PLC309277. Its authorized share capital is ₹25,00,00,000 (₹25 crore), with a paid-up capital of ₹10,15,71,400 (₹10.16 crore).

The company's registered office is located at Unit No. 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Prabhadevi, Mumbai, Maharashtra 400025, India. GNH India Pharmaceuticals Limited specializes in the wholesale trade and commission trade of pharmaceutical products, excluding motor vehicles and motorcycles.

As of March 2026, the company employs between 11 to 50 individuals. GNH India Pharmaceuticals Limited operates a comprehensive product line, supplying over 235,000 medicines, including branded, generic, orphan, and unlicensed drugs.

GNH India Pharmaceuticals Limited collaborates with manufacturing facilities that are WHO-GMP, US FDA, and UK MHRA approved. These facilities specialize in producing branded generics, vaccines, and neutral label products across multiple therapeutic areas and forms. The company emphasizes compliance with international standards to ensure the quality and safety of its pharmaceutical products.

The company's leadership comprises directors Jessica Piyush Gupta, Shwetha Sudarshan Akkela, and Piyush Ashok Gupta. While specific roles and titles are not detailed in the available sources, these individuals are integral to the company's strategic direction and operations.

GNH India Pharmaceuticals Limited's export activities, as per TransData Nexus data, include shipments to various regulated markets, with a total export value of $1.8 million USD across 170 shipments. The company's product portfolio spans 11 products across three therapeutic categories, with a significant presence in the Advanced Oncology category, accounting for 35.5% of exports. Notably, the company holds the #1 market position in Pembrolizumab, with a 14.8% market share. This indicates a strong foothold in oncology therapeutics within these markets.

GNH India Pharmaceuticals Limited's extensive product line, including over 235,000 medicines, positions it to serve emerging markets in Africa, Latin America, and Southeast Asia. The company's adherence to WHO-GSDP and ISO 9001:2015 standards enhances its credibility and facilitates access to these regions. Additionally, its participation in public tenders and direct supply to government hospitals and health departments underscores its commitment to global healthcare accessibility.

GNH India Pharmaceuticals Limited's export data reveals a diversified product portfolio, with the top five products accounting for 93.5% of exports. This concentration suggests a strategic focus on high-demand, high-value products, particularly in the oncology and biologics sectors. The company's global reach, serving over 180 countries, reflects a strategic direction aimed at maximizing market penetration and mitigating risks associated with over-reliance on a single market.

Specific details regarding GNH India Pharmaceuticals Limited's FDA facility registrations, approved ANDAs, DMF filings, and inspection history are not publicly available. However, the company's compliance with international standards, including WHO-GMP, US FDA, and UK MHRA approvals for its manufacturing facilities, indicates a commitment to meeting FDA requirements.

GNH India Pharmaceuticals Limited's manufacturing facilities are WHO-GMP certified, ensuring adherence to international quality standards. While specific details regarding EU GMP certificates and EDQM status are not provided, the company's commitment to quality is evident through its compliance with WHO-GMP and ISO 9001:2015 standards.

The company's manufacturing facilities are licensed by the Indian FDA, indicating compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations. Specific details regarding state drug controller approvals and export No Objection Certificates (NOCs) are not publicly available. However, the company's adherence to WHO-GMP and ISO 9001:2015 standards suggests a commitment to meeting Indian regulatory requirements.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to GNH India Pharmaceuticals Limited. The company's compliance with international standards, including WHO-GMP and ISO 9001:2015, and its licensing by the Indian FDA, suggest a proactive approach to regulatory compliance.

GNH India Pharmaceuticals Limited operates in a competitive landscape with several key players in the pharmaceutical distribution sector. While specific market share comparisons are not available, the company's extensive product line, including over 235,000 medicines, and its specialization in sourcing and supplying essential, specialty, and hard-to-access medicines, position it as a significant competitor. Its focus on regulatory compliance and timely delivery further enhances its competitive edge.

GNH India Pharmaceuticals Limited's key differentiators include its extensive product line of over 235,000 medicines, encompassing branded, generic, orphan, and unlicensed drugs. The company's specialization in sourcing and supplying essential, specialty, and hard-to-access medicines, along with its commitment to regulatory compliance and timely delivery, sets it apart in the pharmaceutical distribution sector.

GNH India Pharmaceuticals Limited's strategic direction focuses on the wholesale trade and commission trade of pharmaceutical products, excluding motor vehicles and motorcycles. The company's extensive product line and specialization in sourcing and supplying essential, specialty, and hard-to-access medicines indicate a commitment to meeting diverse market needs. Its adherence to international standards and regulatory compliance underscores its dedication to quality and global healthcare accessibility.

GNH India Pharmaceuticals Limited's track record includes supplying over 235,000 medicines, indicating a substantial export volume and consistency. The company's compliance with international standards, including WHO-GMP and ISO 9001:2015, and its licensing by the Indian FDA, reflect reliability indicators. While specific export volume and consistency metrics are not publicly available, the company's extensive product line and global reach suggest a reliable supply chain.

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

• FDA Registration: Confirm the company's FDA facility registrations and approved ANDAs through the FDA's official website.

• WHO-GMP Certification: Verify WHO-GMP certification status through the World Health Organization's official website.

• EU GMP Certification: Check for EU GMP certificates and EDQM status through the European Directorate for the Quality of Medicines & HealthCare's official website.

• ISO 9001:2015 Certification: Verify ISO 9001:2015 certification through the International Organization for Standardization's official website.

Importers should undertake the following verification steps:

• FDA Facility Registrations: Confirm the company's FDA facility registrations and approved ANDAs.

• WHO-GMP and EU GMP Certifications: Verify WHO-GMP and EU GMP certifications.

• ISO 9001:2015 Certification: Confirm ISO 9001:2015 certification.

• Regulatory Compliance: Ensure compliance with CDSCO and Indian FDA regulations.

• Export Documentation: Review export No Objection Certificates (NOCs) and other relevant export documentation.

Red flags to watch for include discrepancies in certification statuses, lack of transparency in regulatory compliance, and absence of verifiable export documentation. Recommended pre-order checks involve direct communication with the company to confirm certification statuses and regulatory compliance.