Press Release No. 037/KFCP-DIR/PR/X/20
Jakarta, Indonesia; 1 October 2020: Hetero, one of India’s leading generic pharmaceutical companies and the world’s largest producer of antiretroviral drugs, announced today that its subsidiary ‘PT. Amarox Pharma Global’, in collaboration with Kalbe, is all set to launch the antiviral drug Covifor (Remdesivir) for Covid-19 treatment in Indonesia. Hetero’s Amarox Pharma Global is the first company to receive the Emergency Use Authorization (EUA) approval for the Remdesivir from the Indonesian Food and Drug Authority – BADAN POM.
Aligned with its mission “To improve health for a better life", Kalbe as one of the leading pharmaceutical companies in South East Asia, is committed to support the government in overcoming the COVID-19 pandemic. Leveraging Kalbe's capabilities and nationwide marketing and distribution infrastructure, this collaboration will enable faster and wider access and availability of the drug for COVID-19 patients throughout Indonesia. Given Kalbe's strong network in Healthcare Professionals, hospitals, pharmacies, we hope to accelerate the product roll out to support patient recovery.
The Emergency Use Authorization of Remdesivir is for treatment or laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older with body weight at least 40 kg) patients hospitalized with severe disease.
Covifor (Remdesivir) Injection is being manufactured at Hetero’s state-of-the-art facility in Hyderabad, India, which has been approved by stringent global regulatory authorities such as USFDA and EU. The facility is sufficiently equipped to scale-up the production for meeting large-scale requirements.
In May, Gilead Sciences Inc. extended a voluntary non-exclusive license to Hetero to manufacture and distribute Remdesivir in 127 countries, including Indonesia, expanding access to Covid-19 treatment. In India, Hetero is the first company to launch the generic Remdesivir and has already supplied around 800,000 doses of the drug treating more than 100,000 patients across the country. Besides, the company has also supplied Remdesivir to Asian, African, and some of the Latin American and CIS Countries, as covered under the licensing agreement with Gilead. Remdesivir has been proven to be a game-changer in the battle against Covid-19, given its positive clinical outcomes in terms of safety and efficacy.
Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs. Backed by 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, generics, biosimilars, custom pharmaceutical services and branded generics. The company is globally recognized for its strengths in Research and Development, manufacturing and commercialization of a wide range of products.
Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide, approved by stringent global regulatory authorities. Our portfolio includes 300 plus products encompassing major therapeutic categories such as HIV/AIDS, Oncology, Cardiovascular, Neurology, Hepatitis, Nephrology, Urology, Diabetes, Ophthalmology, Hepatology and Immunology etc.
Hetero has a strong global presence in over 126 countries and focusses on making affordable medicines accessible to patients worldwide.
For more, please visit www.heteroworld.com or click on LinkedIn, Twitter, Facebook
Kalbe at a glance
PT Kalbe Farma Tbk ("Kalbe") was established in 1966 and is one of the biggest public pharmaceutical companies in Southeast Asia. Kalbe has four main divisions that handle reliable and varied brand portfolio: prescription medicines (Cefspan, Hemapo, Broadced, etc.); health product division that handles over-the-counter medication (Promag, Mixagrip, Komix, Woods, Fatigon, etc.); as well as energy and ready-to-consume drinks (Extra Joss, Hydro Coco); nutrition division (ChilKid, Prenagen, Diabetasol, etc.); and distribution division. Kalbe currently has approximately 40 subsidiaries and 12 production facilities with international standard, and employs approximately 17,000 employees dispersed across more than 76 branches throughout Indonesia. From 1991, Kalbe is listed on the Indonesia Stock Exchange (IDX: KLBF).