Vivimed’s FDF facility in Alathur completed successful USFDA inspection

India Infoline News Service | Mumbai | November 30, 2016 08:58 IST

The audit was conducted during the last week of November and concluded on November 28,2016.

Vivimed Labs Limited ("Vivimed" or the Company), a niche Specialty Chemicals and Pharmaceuticals company, announced that its FDF manufacturing facility located in Alathur, near Chennai has had a favourable outcome post its US Food and Drug Administration (USFDA) inspection. The audit was conducted during the last week of November and concluded on November 28,2016. Furthermore, Vivimed obtained ANDA approval for Metronidazole and same is commercialised.

During November 2016, the Company acquired ANDA of Zolpidem and the file transfer has successfully been completed. It is expected to be commercialised by Q4 FY2017. Vivimed is on track of its filing targets and has successfully completed 3 ANDA filings during FY2017 and expect one more filing to be completed by Q4 FY17. These products provide vertical integration with the inhouse APIs. Over the two years we have received satisfactory outcomes of USFDA inspections for our two plants in Spain, one in Mexico and one in India."

For the India plant, this was the second inspection, Santosh Varalwar added.

"We believe that this satisfactory outcome will support our endeavour to further strengthen our positioning in the global markets," Varalwar said.

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