Jakarta, September 26, 2024 – PT Kalbe Farma Tbk (Kalbe) supports the government in developing innovations in the field of stem cell and biotechnology production facilities. The Indonesian FDA (BPOM/Badan Pengawas Obat dan Makanan) supports Kalbe’s efforts. The support is marked by the visitation of the Taruna Ikrar, the Chairperson of BPOM to Kalbe Business Innovation Center in East Jakarta and PT Kalbio Global Medika in Cikarang. This visit by the Chairperson of the BPOM is a synergy between the government and the health industry towards improving the resilience of national health.
“Today’s BPOM visit is a crucial moment and has given Kalbe the encouragement to keep moving forward towards producing good products and services that are safe for the people. We hope that through this meeting we can continue to share information, discuss, and improve synergies with industry actors and regulators,” says the President Commissioner of PT Kalbe Farma Tbk, Vidjongtius.
Kalbe’s stem cell production facility has been certified with CPOB (Cara Pembuatan Obat yang Baik/Good Medicine Manufacturing Process) from the BPOM, in regards to stem cell processing facility that belongs to Kalbe’s subsidiary, PT Bifarma Adiluhung (Regenic) since 2014. This stem cell processing facility is the first of its kind that holds a CPOB certificate.
Today, Kalbe actively collaborates with the Directorate of Drug Production Control (Direktorat Pengawasan Produksi Obat) of the BPOM, including when Kalbe moved their stem cell processing site from Pulomas to the location at Kalbe Business Innovation Center in 2021. In the same year, Kalbe also obtained the Approval of Assessment of New Developmental Drug (Persetujuan Penilaian Obat Pengembangan Baru) for UCMSC & Secretome.
The Chairperson of BPOM also visits Kalbe’s production facility that focuses on biological drugs, Kalbio Global Medica. This production facility, that was inaugurated by President Joko Widodo in 2018, has also been CPOB-certified by the BPOM.
“This production facility is one of about 20 production facilities/factories that Kalbe owns. Kalbe has four lines of business: pharmaceutical/prescription drugs, nutritional products, health products, and the distribution and logistics of pharmaceutical tools,” says the Director of PT Kalbe Farma Tbk, Sie Djohan.
“Kalbe supports BPOM’s crucial role as the responsible institution in ensuring the safety, impact, and quality of all products that are in distribution in the society. We think that a strong synergy between BPOM and actors in the health industry would become a key to ensure our shared success in providing the best healthcare solutions for the people,” concludes Vidjongtius.