Facility

Current Plant capacity

• Dry Powder for Injection: 1.5 million/month
• Tablets: 17.00 million/month
• Capsules: 4.50 million/month
• Dry syrups: 0.25 million/month
• Sachets: 0.50 million/month

(Capacity based on one shift – 8 hour operation)

Production

Our dedicated state-of-the-art facility for Cephalosporin antibiotic formulations is equipped to manufacture almost all dosage forms like Dry powder for injections/Tablets/Capsules/ Dry syrups and Sachets. The manufacturing facility has been designed for a uni-directional flow of men and material. The unit is laid out with full epoxy flooring, complemented by dedicated HVAC systems for required environmental control.

The sterile dry powder injections are manufactured within ISO Class-5 area under controlled particulate matter and environmental conditions. Our manufacturing unit prides itself in running a single line, fully automated sterile dry powder injection manufacturing facility.

The non sterile dosage forms (Tablets, Capsules, Dry syrups and Sachets) are manufactured under ISO Class 8 area at controlled environmental conditions using advanced cGMP machineries.

Quality control

The quality control laboratory is facilitated with advanced instruments along with a competent team to ensure that the required tests are executed in line with USP/BP/IP/Ph.Eur/IH standards. The raw materials are released for use and the finished products are released for supply, only after their quality has been confirmed to comply with predetermined specifications and standards. Our quality control department has 5 sections- Chemical analysis, Instrumental analysis, Packing material testing, Microbiological analysis and stability study section. The quality control laboratory is equipped with 21 CFR part 11 compliant instruments viz. HPLC, GC, FTIR, TOC, UV, Dissolution apparatus, Air sampler, Walk – in stability chambers, Ovens, incubators and Laminar air flow units etc.

Quality Assurance

We are focused on constantly improving the quality standards of our products and practices by implementation of cGMP with various international regulatory standards, up-gradation in technology; imparting training to effectively adapt to newer technologies and regulations. Sance’s facility is well equipped with Quality Assurance team with experience and knowledge of latest quality standards and cGMP practices. Some of the significant QA responsibilities are Quality management system, Quality Risk Assessment, Documentation control, Monitoring in-process manufacturing & testing activities, Finished product release, Training and development, Qualification /Validation of equipment /Process, Self inspection etc