Leading SMEs of India 2022

Sakar Healthcare Limited, with two decades of presence in pharmaceutical general formulation manufacturing, export and CDMO business, has expanded with newly inaugurated research-driven API-integrated oncology formulation manufacturing unit located at Bavla, Gujarat, India. The unit is vertically integrated to provide one-stop solution right from research and development to scale up commercial batches. The Research unit has started developing highly complex molecules as the lab is equipped with world-standard Vapourtech R-Series equipment, UK to ensure most efficient flow-chemistry technique. • The unit has made ready five anti-cancer molecules with process completion from R&D to Gram to Pilot to Commercial scale • Ongoing development of a patented, non-infringing product presently ranked amongst top five- valued over $5 billion worldwide for a European partner The WHO approved and EU GMP compliant API plant has been suitably equipped with 11-glass line reactors from De- Dietrich, Italy with containment technology, controls and capabilities for safe manufacturing and handling of highly- potent APIs (HPAPI). The varied manufacturing capacity of Pilot area (1.00 Kg to 10.00 Kg), Intermediate area (25kg to 80 kgs), Gram scale area (10 gm to 500 gm) allows flexibility in manufacturing batches of diverse size. This unit offers • phase-wise scale up studies with impurity profiling, stability studies, risk analysis studies and production from gram scale to kilo scale with all cGMP documentation in HPAPI containment area • Pilot plant validation for technology transfer with subsequent scale up for Intermediates under CRAMs • Process validation with complete PDR as per QBD concept for development products The WHO certified oncology Oral Solid Dosage (OSD) block has been strategically designed to cater to multiple batch sizes and product range. The unit has been articulated with granulation and compression containment equipment from GEA, Belgium, auto-coater from Glatt, Germany, visual inspection machine from Sensum, Slovenia, bulk packaging line from IMA, Germany. The plant has • Enabled for pilot scale manufacturing of five internally developed products • Process for dossiers with CoPP for Tablets, Capsules to file in respective regions for Marketing Authorizations to export • Amongst valued partners like Baxter, Ferring, Zydus, Torrent pharmaceuticals, agreement has already been signed-off with Zydus Lifesciences (Cadila Healthcare); has received technology transfer for key OSD products (includes process validation, stability and qualification) to scale up commercial production. The injection block offers liquid, lyophilised and lipid complex injections having fully automatic liquid filling & stoppering machine along with 100% online weighing systems. The two lyophilisers of 10 & 5 metre square with automatic vial loading & unloading system from Tofflon with isolator operates under Class A environment protected by positive pressure isolator. • The EU GMP compliant unit is equipped to manufacture diverse anti-cancer products • The plant is flexible in design to handle simple to complex injection molecules Comply to stringent regulatory compliance includes Eurovent certified AHU, Water system-two pass RO with EDI, ETP (zero- discharge) along with other utilities, abiding by principles of Green Chemistry, as Founder & Managing Director, Mr.Sanjay Shah has mentioned “Sakar is at crux of next phase of growth, entering the niche segment of Oncology to cater to humanity. Sakar is well equipped to deliver high precision Research works, suitably followed by Technology Transfer and Scale-up to commercialize Anti-Cancer products worldwide.” Sakar Healthcare Limited Delivering Integrated Solution with Oncology Products 406, Silver Oaks Comm. Complex, Opp. Arun Society Paldi, Ahmedabad-380 007, Gujarat, India 079 26584655 079 26588054 info@sakarhealthcare.com www.sakarhealthcare.com Stay connected with us @ linkedin.com/company/sakar-healthcare facebook.com/sakarhealthcare Mfg. Unit: Changodar, Gujarat, India - EU GMP Approved SVP (Injection), Cephalosporin, Oral Liquid Mfg. Unit: Bavia, Gujarat, India - Oncology Research, API, Formulations (Oral Solid, Injection) Dun & Bradstreet