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HomeLatest Pharma-NewsCo-Diagnostics Gets “Indian FDA” Approval for Infectious Disease Testing (in vitro diagnostic...

Co-Diagnostics Gets “Indian FDA” Approval for Infectious Disease Testing (in vitro diagnostic assays)in One of the World’s Biggest Markets

Dec. 03, 2019: Co-Diagnostics  Inc. announced that Indian regulators have approved five in vitro diagnostic assays to be manufactured and sold by CoSara Diagnostics Pvt Ltd., the company’s joint venture for manufacturing in India.

The approved tests are used for tuberculosis, malaria, hepatitis B, hepatitis C, and human papillomavirus.

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The Indian Central Drug Standard Control Organization (or “CDSCO”) is the regulatory body that is responsible for the approval of pharmaceuticals and medical devices for their use in the Indian healthcare market, serving the corresponding function as the Food and Drug Administration in the United States, making CDSCO approval in India analogous to FDA approval in the United States. inauguration of the JV manufacturing plant earlier this year as  announced by Co-Diagnostics.


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