BPOM Conferred A GMP Certificate For Biotechnology Products Non-vaccine Upon KGM
Last December 2021, Mrs. Ratna Sosialin, Quality General Manager from PT Kalbio Global Medika, received a Good Manufacturing Practice (GMP) certificate for Biotechnology Products Non-vaccine from the Indonesian Food and Drug Authority (BPOM), which legitimates until October 2026.
A Good Manufacturing Practice (GMP) Certificate is a legal document showing pharmaceutical industries' compliance with the GMP requirement when producing drugs, while GMP itself means a system to make sure that the drugs manufacturing is in accordance with the regulatory and quality standards.
This accomplishment puts KGM in an enthusiasm and spirit to keep providing good quality medicines for everyone in need, whilst always complying with the procedure in hope to improve health for a better life.
KGM at a Glance
Kalbio Global Medika (KGM) is one of the first and the pioneer of biopharmaceuticals in Indonesia, established in 2014 and inaugurated officially in 2018 by the President of the Republic of Indonesia, Ir. Joko Widodo. KGM is part of the Kalbe Group, a subsidiary of PT Kalbe Genexine Biologics (KGbio), which is a clinical-stage biotechnology company focused on bringing biologics medical innovation to markets outside US/Canada, Western Europe, and China. KGM is an Innovative CDMO, equipped with CMC and scale-up capabilities plugged into Boston biotech ecosystem and state-of-the-art facility to enhance efficiency and productivity. With API manufacturing, formulation, fill and finish capabilities of biosimilar and novel biologics, averaging 10 million units of syringes, cartridges, and vials, KGM supplies local and international markets.
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