|
The US Food and Drug Administration (USFDA) inspected Indoco's sterile manufacturing facility in Goa (plant II) from 7th to 15th October 2019. The audit was concluded successfully.
The inspection ended with 2 observations, neither of these are related to data integrity or the core quality management system. The company will respond to the FDA within the stipulated time. The site continues to maintain its VAI (voluntary action indicated) status.
“This is the second successful Pre-Approval Inspection (PAI) of this site in less than 6 months, which indicates steady progress in review of our pending ANDAs. The Company has 39 ANDAs pending for approval from this site”, said Aditi Kare Panandikar, managing director - Indoco Remedies.
Meanwhile, the S&P BSE Sensex was up 94.20 points or 0.24% to 38,600.29.
On the BSE, 7,386 shares were traded in the counter so far compared with average daily volumes of 1.63 lakh shares in the past two weeks. The stock hit a high of Rs 155.4 and a low of Rs 134 so far during the day.
The stock hit a 52-week high of Rs 238 on 26 Nov 2018. The stock hit a 52-week low of Rs 133.1 on 11 Oct 2019.
Indoco Remedies will consider Q2 September 2019 results on 30 October 2019.
On a consolidated basis, Indoco Remedies reported a net profit of Rs 1.85 in Q1 June 2019 as against a net loss of Rs 12.19 crore during Q1 June 2018. Net sales rose 16.18% to Rs 247.18 crore in Q1 June 2019 over Q1 June 2018.
Indoco Remedies is a fully integrated, research-oriented pharma company with presence in 55 countries.
|