Sakar Healthcare Ltd incorporated in 2004 has emerged as a leading pharmaceutical manufacturer based in Western India, specialized with innovative oncology solutions.
With the research-driven API-integrated EU GMP approved oncology orals & injection formulation manufacturing units, Sakar is ready to cater the global markets with diverse product range and business models.
The process of submission of eCTD dossiers for marketing authorizations/ registrations of 30 identified anticancer molecules is ongoing in EU along with Mexico, Philippines, Ethiopia, Vietnam. The Bioequivalence studies for the OSD has been carried out through FDA/EU approved CRO’s using RLD procured from EU regions. For sterile Injections, critical process of filter and sterility validation, tests like extractability-leachability test, bacterial endotoxin have been followed. You may check for the technical capabilities at https://www.youtube.com/watch?v=pdMIvAzfVkw=)
The modern facility has as integral parts
Research and Development: The research labs employ cutting edge technologies to streamline processes like flow-chemistry (Vapoutech, UK), ensuring the highest standards in drug development from concept to high grade molecules. With combined efforts of the Research team, Sakar has received a Process Patent for Imatinib for preparation using Vilsmeier reagent and presently developing oncology products for partners originating from Greece, Switzerland and India.
Manufacturing blocks:
EU-GMP approved Oral Solid Dosage: Production capabilities includes 56 million tablet and 29 million capsule productions annually in single shift, utilizing advanced fully containment equipment from GEA (Belgium) and other equipment from across the globe ensuring minimum human interference.
Injectables: Featuring isolators and sophisticated lyophilization systems with automatic vial loading and unloading system, ensures an annual capacity of 13 million vials of 10ml and 30,000 lyophilized vials of 10ml per cycle.
EU GMP approved Oral Liquid: The R&D team has developed Oral Liquid oncology products in-house and are now ready to scale-up batches from our EU-GMP approved facility post completion of PV Batches & stability studies.
API Manufacturing: Equipped with glass-line reactors and automated systems to handle cytotoxic products at various scales. Plant capacity including pilot & gm scale is approx 10 tons per annum. 21 API’s have been developed where 10 have written confirmation, 19 with DMF open part and 7 prepared with CEP.
Sakar Healthcare has been into pharmaceutical manufacturing and exports for two decades having global footprints across 4 continents. The four blocks manufacturing formulations: oral liquids, antibiotics (oral solids), antibiotics (DPI) and small volume parenteral (liquid/lyophilised injections in vials and ampoules) covers over 24 therapeutic segments. The plant has received regulatory approvals from 15 MOH globally including EU-GMP for small volume parenteral Sakar has been a preferred partner under CDMO for global players including Zydus Life Sciences, Ferring Pharmaceuticals, Torrent Pharma, Baxter, Intas, Merck.
With flexible Business models includes
· co/development
· partnering technology-transfer
· scale-up developed products
· out-licensing
· CDMO globally
Sakar Healthcare stands as one stop solution for partnerships and collaborations with wider range.
Company is listed at National Stock Exchange, Mumbai India and aspires to to differentiate with vertical integration and value added products:
1. Liposomal (Doxorubicin)
2. HME (Apalutamide, Enzalutamide, Olaparib)
How to contact us?
Bikramjit Ghosh | VP-Strategy & Business Development
Email: bikramjit@sakarhealthcare.com |
Mobile: +91 966 254 5510
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