Divi's Labs spurts after resolving previous observations of facility with USFDA

Capital Market 

Divi's Laboratories gained 5.99% to Rs 915.60 at 12:03 on after the company said that all previous observations of unit-2 of its Visakhapatnam facility have been confirmed as completed and resolved after US drug regulator's inspection.

The announcement was made during market hours today, 20 September 2017.

Meanwhile, the S&P Sensex was down 0.92 points, to 32,401.45.

High volume was witnessed on the counter. On the BSE, 9.35 lakh shares were traded in the counter so far, compared with average daily volumes of 2.93 lakh shares in the past one quarter. The stock had hit a high of Rs 919.50 and a low of Rs 866.45 so far during the day. The stock had hit a 52-week high of Rs 1,355.45 on 20 September 2016. The stock had hit a 52-week low of Rs 533.10 on 29 May 2017.

The stock had outperformed the market over the past one month till 19 September 2017, gaining 36.23% compared with 2.78% gains in the Sensex. The scrip had also outperformed the market in past one quarter, rising 33.87% as against Sensex's 3.48% rise. The scrip had, however, underperformed the market in past one year, falling 35.58% as against Sensex's 13.16% rise.

The large-cap company has equity capital of Rs 53.09 crore. Face value per share is Rs 2.

Divi's Laboratories said that all previous observations have been confirmed as completed and resolved of unit-2 of its Visakhapatnam facility after inspection carried out by United States Food & Drug Administration (USFDA) from 11 September 2017 to 19 September 2017.

This inspection was for full cGMP and verification of all corrective actions proposed against the previous Inspection observations.

On completion of this inspection, Divi's Laboratories has received a Form 483 citing six observations which are procedural and the company will be responding to these within the stipulated time.

The USFDA had issued an import alert on the unit II of the company in March and a warning letter to the same in May. The plants that are on FDA's import alert are not permitted to export drugs to the US.

Divi's Laboratories had said in April that USFDA had exempted some more products manufactured at the company's unit-II at Visakhapatnam from the import alert issued under clauses 66-40 & 99-32 of the FDA regulations.

Divi's Laboratories' net profit fell 41.5% to Rs 176.54 crore on 19.3% decline in net sales to Rs 821.20 crore in Q1 June 2017 over Q1 June 2016.

Divi's Laboratories is primarily engaged in the manufacture of active pharmaceutical ingredients (APIs) & intermediates for generics; custom synthesis of API's and advanced intermediates for discovery compounds for pharma giants; building blocks for peptides; building blocks for nucleotides; carotenoids; and chiral ligands.

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First Published: Wed, September 20 2017. 12:23 IST