Sakar Healthcare announced today that its oncology unit located in Bavla, Gujarat, has received a three-year European Union Good Manufacturing Practice (EU GMP) approval. This certification signifies that the unit meets the strictest international standards for manufacturing quality pharmaceuticals.
The facility boasts advanced equipment capable of producing a wide range of research-driven oncology formulations, including liquid injections, lyophilized injections, tablets, capsules, and granules. The European Agency audit team conducted a thorough inspection in late 2023, ultimately granting approval for both oral solid dosage and injection products.
This achievement builds upon Sakar Healthcare's existing WHO GMP certification, which has allowed the company to successfully manufacture and sell oncology products within India. Notably, the company has developed 30 generic anti-cancer molecules and efficiently transferred the technology to its manufacturing units.
Further, Sakar Healthcare has made significant strides in regulatory compliance. The company has prepared Common Technical Documents (CTD) dossiers, conducted bioequivalence studies, completed process validation, and generated stability data for both oral solid dosage forms and injections. Additionally, 11 of their oncology Active Pharmaceutical Ingredients (APIs) have received Written Confirmation for export to the European Union.
The EU GMP certification, coupled with Sakar Healthcare's internal preparedness, opens doors for significant export opportunities. The company is actively engaged in discussions regarding business contracts, dossier submissions, and supply agreements, with the potential to tap into the vast European market and other regulated regions. This expansion presents a chance for substantial growth and strengthens Sakar Healthcare's position in the global oncology market.
The fully integrated oncology unit offers a distinct competitive advantage through its comprehensive capabilities and streamlined production processes.
Sakar Healthcare is engaged in manufacturing of pharmaceutical products providing liquid orals, cephalosporin tablet, capsule, dry powder syrup, dry powder injections, liquid injectables (SVP) in ampoules and vials & lyophilized injections. Its products are exported worldwide.
On a consolidated basis, net profit of Sakar Healthcare declined 48.38% to Rs 2.07 crore on 11.23% increase in net sales to Rs 37.23 crore in Q3 December 2023 over Q3 December 2022.