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Nepal Department of Drug Administration (DDA) Visited PT Kalbio Global Medika

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The National Agency of Drug and Food Control (NA-DFC) of Indonesia (BPOM Indonesia) was holding Visitation Learning Program from Department of Drug Administration (DDA) of Nepal which is facilitated by USAID MTaPS Indonesia. USAID is the organization leading international development and humanitarian efforts to save lives, reduce poverty, strengthen democratic governance and help people progress beyond assistance. USAID works with partners to strengthen pharmaceutical systems in low- and middle-income countries. USAID builds The Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program. MTaPS is implemented by a consortium, blending experience from prior USAID-funded PSS initiatives with updated and local expertise to effectively and sustainably help countries develop stronger pharmaceutical systems.

This Visitation Learning Program aimed to introduce the function of mature National Regulatory Authority (NRA) to Nepal DDA officers. Currently, NA-DFC of Indonesia (BPOM Indonesia) is NRA which has achieved level 3-4 of maturity level of WHO NRA Benchmarking. The Nepal DDA officers visited Ministry of Health, PT Kalbio Global Medika (KGM) as one of the biggest pharmaceutical industries in Indonesia, and medical devices industry. By performing visitation to pharmaceutical industry, Nepal DDA officers learn the implementation of drug control. In addition, Nepal DDA wanted to see the industry capacity in Indonesia which potentially exports the medicines to Nepal.

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Site visit to the manufacturing site of PT Kalbio Global Medika was held on 29 Aug 2022 at Cikarang, West Java. The representatives from Nepal DDA who visited KGM were Mr. Narayan Prasad Dhakal as the Chief Drug Administrator, Ministry of Health and Population from Nepal DDA, and Mr. Nikesh Shrestha who is a Nepal DDA Pharmacy Officer. Arry Lesmana Putra, the country project director of USAID MTaPS Indonesia, and some representatives from NA-DFC of Indonesia (BPOM Indonesia), also joined the site visit to KGM. During the visit, Nepal DDA was invited to production facilities from API production facilities up to formulation-fill-finish facilities.


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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