The company’s dossier compiled under EU guidelines have fetched this second approval in continuation to the journey of their research-driven API-integrated EU GMP approved oncology formulation manufacturing unit.
While the earlier product intends to treating breast cancer, non-small cell lung cancer and prostate cancer, this second one is for treating colorectal cancer; both are widely prevalent type of cancers.
"Strategically the second MA now widens the door to export and commercialise injection products to the European countries, with the first MA that received approval in April-2025 is in process of its FIRST commercial supply,” Sakar Healthcare stated.
It further said that with another few products (mix of liquid, lyophilised injections and oral solids) presently under registration in the EU, the company expects the grant of these MAs one-by-one within next few months.
These MAs will speed up the export of multiple oncology products to the EU region manufactured at Sakar’s state-of-the-art vertically integrated oncology product manufacturing site.
Sakar Healthcare manufactures pharmaceutical formulations in the form of liquid injectables, tablets/ capsules, oral liquid syrups, dry powder injections and syrups. The company manufactures generic formulations in 24 therapeutic categories, such as antibiotics, cough preparations, vitamins and mineral supplements, among others. Also, the company entered the oncology drugs segment with units for oncology formulations, APIs and injectables.
The company's consolidated net profit surged 84.62% to Rs 5.76 crore as revenues increased by 16.67% to Rs 50.24 crore in Q4 FY25 as compared with Q4 FY24.