Kathmandu: Zydin Biotech Ltd., reported as Nepal’s first producer of raw materials for cancer medicines, has received Good Manufacturing Practices (GMP) certification for its Active Pharmaceutical Ingredient (API) manufacturing block.
According to the certificate supplied by the company, the Department of Drug Administration issued the certification on October 9, 2026, following an inspection conducted on August 25–26. The certificate remains valid until October 8, 2028, subject to continued compliance with GMP requirements.
The certified facility is located in Sharanpur, Bharatpur–16, Chitwan. Its approved scope covers cytotoxic APIs, including synthesis, purification, packing, labelling, quality control and quality assurance.
APIs are the active ingredients in medicines that produce their therapeutic effects. Zydin Biotech says its focus is on producing high-quality APIs used in cancer treatment.
The company has previously produced cancer drug raw materials using locally sourced Himalayan yew and exported materials to India, according to earlier reports.
Announcing the certification, Zydin Biotech described the achievement as a milestone for Nepal’s pharmaceutical industry. The company said expanding domestic API manufacturing could help reduce dependence on imports and strengthen the country’s pharmaceutical supply chain.
It credited its team, management and collaborators for the achievement and reaffirmed its commitment to developing Nepal’s pharmaceutical manufacturing capabilities.
