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Virchow Products
Regulatory and Dossier support

Apart from approvals from Drug Control General of India (DCGI), and Department of Biotechnology and Department of Science & Industrial research (Government of India), Virchow’s regulatory team has also received several USFDA 510(k) approvals and CE approvals for medical devices and ANVISA (Brazil), INVIMA (Colombia), PICS (Ukraine) for in-house biological products.

Virchow is the first Indian biotech player to get an ANVISA approval and INVIMA approval for recombinant products. Given this great regulatory strength, Virchow has been able to expand quickly in international markets and has already gained access to Ukraine, Russia, Brazil, Colombia, Turkmenistan, Cambodia, Myanmar, Sri Lanka, Philippines, Uganda, and Kenya.

News & Events

Virchow Biotech is filing for U.S.Food and Drug administration’s (FDA) approval for its in house developed advanced wound care products.

Virchow Biotech received Drug control’s (DCGI) approval for conducting clinical trials on periogen, an indigenously developed recombinant therapeutic product for periodontal diseases

Virchow Biotech and Ranbaxy signed an MOU to market Virchow’s indigenously developed recombinant therapeutic protein for osteoporosis treatment. We are the first in the world to launch this biogeneric product