CoSara Diagnostics Pvt. Ltd
CoSara Diagnostics Pvt. Ltd has exclusive manufacturing rights in India for the complete menu of all products engineered using Co-Dx’s proprietary design process and patented Co-Primers™ technology.
Since December 2019, CoSara Diagnostics has received approval by the India Central Drugs Standard Control Organization (CDSCO), the national regulatory authority of India for several in vitro diagnostics (IVD) built using the Co-Primers technology, including:
- Chikungunya
- COVID-19 (single-gene)
- COVID-19 (multi-gene multiplex)
- Dengue-Chikungunya Multiplex
- Dengue Virus
- HBV – Viral Load
- HCV – Viral Load
- Hepatitis B (HBV)
- Hepatitis C (HCV)
- HPV – High Risk
- Human papillomavirus (HPV)
- Influenza A/B & COVID-19 Multiplex
- Malaria
- Mycobacterium tuberculosis
Background
In January 2017, Co-Dx and Synbiotics Limited, a group company of Asence Inc., our global partner and a U.S.-based company specializing in supplying pharmaceutical products to international markets, entered a Joint Venture (JV) agreement and formed “CoSara Diagnostics Ltd.” for the purpose of establishing a manufacturing location in India to manufacture products for distribution and sale in India initially, and, upon agreement, for worldwide markets.
Later in 2017, CoSara Diagnostic’s Good Manufacturing Practices (GMP) facility was one of the first of its kind in India to manufacture IVD products designated for clinical use. The JV facility in Ranoli, India was inaugurated in April 2019 to manufacture Co-Dx products under the label of CoSara Diagnostics, Pvt. Ltd according to the internationally recognized Current Good Manufacturing Practices (cGMP) standards. CoSara’s facility was one of the first of its kind in India licensed to manufacture IVD products designated for clinical use.
Learn more about Co-Sara at cosara.in.
