Acoris Research Ltd a state-of-the-art contract research facility and a 100% subsidiary of Hikal Ltd, received the Good Manufacturing Practices (GMP) certification from the Food & Drugs Administration (FDA), Maharashtra.
“The GMP accreditation received by Acoris is yet another recognition from an approved body which validates the Quality Management Systems and procedures adopted and followed at Acoris. This will help Acoris to cater to its customer requirements for cGMP materials in the early development phase. It will also broaden the offerings of the Hikal group as it provides this service on a commercial scale” said Dr. R. Helmut Rupp, President, Acoris Research Ltd.
The layout at Acoris has been designed to cater to GMP norms and to fulfill class 100,000 requirements. It comprises of two 20 lt. & one 50 lt. jacketed glass equipment which can be operated from -300C to 1800C. In addition, one special 50 lt. glass vessel can be operated -900C to 1800C with cooling/heating fluid. The installations are supported by feed vessels (2), distillation facilities with receivers (2), scrubbers and a spray ball cleaning system and are connected to PLC (Rockwell) for monitoring/alarm. The downstream equipment includes a filter nutsch, a centrifuge, holding tanks, a vacuum tray dryer with mill and sifter.
GMP is a regulatory requirement that is recognized worldwide for sound quality principles. Under GMP guidelines, all critical processes are validated to ensure consistency and compliance with specifications.
About Acoris Research Ltd,
A wholly owned subsidiary of Hikal Ltd. Acoris is a state-of-the-art contract research facility situated at the International Biotech Park in Pune, India. Acoris delivers contract research and manufacturing services to innovator companies and provides customized services, from Full Time Equivalent (FTE) to Fee for Service (FfS) contracts. Acoris helps customers innovate during the early lifecycle of their products with a comprehensive suite of offerings including Route Scouting, Contract Research, Process Development, Scale up, Analytical Method Development and cGMP (kilo) Manufacturing.
For more information about Acoris, visit www.acorisresearch.com
About Hikal Ltd.
Hikal is a reliable long-term outsourcing partner to companies in the Pharmaceuticals, Crop protection Products, and Specialty Chemicals industry. The company has been supplying key active pharmaceutical ingredients (API’s) and intermediates, manufactured using stringent global quality standards, for its customers in the United States, Europe and Japan. Hikal’s advanced manufacturing facilities have been inspected and approved by leading global players in the Pharmaceutical industry.
For more information about Hikal, visit www.hikal.com