May Or June Of This Year, The COVID-19 Drug Molnupiravir Is Ready To Be Produced Domestically

JAKARTA - Head of the Food and Drug Supervisory Agency (BPOM) Penny K. Lukito estimates that the COVID-19 antiviral drug Molnupiravir will be ready for domestic production in May or June 2022.

"Estimated local production of Molnupiravir in May or June 2022," he said at the Hearing Meeting (RDP) which was attended by the Indonesian House of Representatives Commission IX YouTube in Jakarta, Antara, Tuesday, January 18.

Penny added, PT Amarox Pharma Global as a subsidiary of Hetero Labs Ltd, India will produce Molnupiravir hard capsules in Indonesia.

"Currently PT Amarox has obtained a production permit and is building a facility that will be used for production. BPOM is assisting with the requirements for Good Manufacturing Practices of Medicine (CPOB)," he said.

BPOM is currently still providing assistance in fulfilling the GMP requirements after the Letter of Approval for the Use of Hard Capsule Facilities for the production of Molnupiravir was obtained by PT Amarox on January 3, 2022.

Apart from PT Amarox, said Penny, PT Kimia Farma also plans to produce Molinupiravir and has obtained a medicines patent pool (MPP) license.

"Currently, we are in the process of preparing the dossler and the WHO PQ facility. It is hoped that by June 2022, the application will be submitted to WHO and it will be ready for production," he said.

In this activity, Penny also reported on the readiness of domestic production of the COVID-19 antiviral drug Favipiravir.

Currently, there are five pharmaceutical industries that have obtained Emergency Use Permits (EUA) for local production, namely Kimia Farma, Kalbe Farma, Novell, Amarox Pharma Laboratories Global, and Lapi Laboratories.

"Those five pharmaceutical industries are already active in production, namely Kalbe Farma and Kimia Farma," he said.

According to Penny, Amarox, Novel and Lapi are not yet in production because they are still preparing for packaging production and stability testing.

"We continue to oversee and monitor the quality of the production of the drugs they make," he said.