Sakar Healthcare Limited has achieved a key regulatory milestone after its oncology manufacturing facility in Gujarat was approved by the European Medicines Agency (EMA) for the production of Imatinib tablets for the European market. The approval allows Sakar’s oncology site located at Bavla–Bagodara Highway, Ahmedabad, to manufacture Accord Healthcare’s finished dosage formulations of Imatinib Accord 100 mg and 400 mg film-coated tablets for supply across Europe.
The development follows the successful completion of a transfer variation process, which received clearance from the EMA. The approval marks the outcome of coordinated efforts between Accord, Intas, and Sakar Healthcare, enabling the Bavla oncology unit to be added as an authorized manufacturing site for this product.
With this approval in place, Sakar Healthcare’s oncology facility has now become a manufacturing source for Accord’s European market for Imatinib 100 mg and 400 mg tablets. Notably, Imatinib is the first of nine oncology products from Accord that are planned to be transferred to Sakar’s manufacturing site, highlighting a broader collaboration pipeline between the companies.
The inclusion of Imatinib in Sakar’s export portfolio is expected to support higher capacity utilisation at the oncology unit and is likely to have a positive impact on the company’s top-line performance in the coming financial year. The development also strengthens Sakar’s presence in regulated markets, particularly Europe, which requires stringent compliance with quality and regulatory standards.
In addition, the approval enables Sakar Healthcare to prepare for overseas supplies of around a dozen approved products, further expanding its international oncology footprint.
