fdc

DCGI directs manufacturers of FDCs to manufacture, market certain FDCs based on Bombay HC directive

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DCGI directs manufacturers of FDCs to manufacture, market certain FDCs based on Bombay HC directive

With regards to the FDC- Cefadroxil + Clavulanic acid, manufacturers have been directed to submit the protocol for conducting in-vitro study to prove the efficacy of this combination to this office for approval. Drugs Controller General of India (DCGI) has directed all the manufacturers of Fixed Dose Combinations (FDCs) – Cefixime + Cloxacillin, Cefixime + … Read more

DCGI directs pharma companies to submit information of pre-1988 permitted FDCs on their safety and efficacy

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DCGI directs pharma companies to submit information of pre-1988 permitted FDCs on their safety and efficacy

The DCGI notice on FDCs has been sent to the Indian Drug and Pharmaceuticals Associations and also uploaded on the website of CDSCO for information and necessary action by the concerned stakeholders. The Drugs Controller General of India (DCGI) has directed pharma companies to submit information of certain pre-1988 permitted Fixed Dose Combinations (FDCs) on … Read more