Indoco Remedies shines post USFDA issues zero observation
Indoco Remedies a fully integrated, research-oriented pharma Company informed the bourses today that its Clinical Research Organisation (CRO), AnaCipher, located at Hyderabad has cleared the USFDA (United States Food and Drug Administration) inspection with zero 483s. This inspection was carried out from 14th to 18th October, 2019. AnaCipher CRO is a division of Indoco, specialized in Bio-Availability and Bio-Equivalence (BA / BE) studies.
The company’s management commented that this achievement is for the fifth time in a row. The API and CRO business accounted for around 11 per cent of total revenue in FY19. The company’s domestic formulation contribute majorly i.e. 64 per cent of total FY19 revenue.
Earlier, the company’s Goa Plant II was inspected by USFDA from 7th to 15th October 2019 which ended with 2 observations. The company said that of these two observation neither is related to data integrity or the core quality management system. This facility continues to operates as VAI which means FDA found objectionable conditions, but they did not warrant regulatory significance.
With response to this positive development, the stock of Indoco Remedies jumped on the bourses by nearly 7.2 per cent to touched intra-day high of Rs. 154.70 apiece.