SPARC, Sun Pharma drop on USFDA revocation of approval to drug

Sun Pharmaceutical Industries shed 2.73% to Rs 866.95 at 13:40 IST on BSE after the US Food and Drug Administration revoked an approval issued to the drugmaker, citing manufacturing quality problems at its production site.

Shares of Sun Pharma group company, Sun Pharma Advanced Research Company (SPARC) dropped 2.6% to Rs 375.85.

SPARC had made the announcement on Saturday, 26 September 2015.

Meanwhile, the BSE Sensex was down 17.38 points, or 0.07%, to 25,851.94.

On BSE, so far 1.31 lakh shares were traded in the Sun Pharmaceutical Industries' counter, compared with an average volume of 3.19 lakh shares in the past two weeks.

The stock hit high of Rs 894 and low of Rs 857.50 so far during the day. The stock hit a record high of Rs 1,200.70 on 7 April 2015. The stock hit a 52-week low of Rs 748.15 on 26 September 2014.

The stock had underperformed the market over the past one month till 24 September 2015, rising 0.02% compared with 0.47% rise in the Sensex. The scrip had also outperformed the market in past one quarter, gaining 2.35% as against Sensex's 6.73% fall.

The large-cap company has an equity capital of Rs 240.65 crore. Face value per share is Re 1.

Sun Pharma Advanced Research Company (SPARC) announced that the US Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to its New Drug Application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg).

SPARC had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialization. However SPARC has now received a CRL from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval.

Elepsia XR is to be manufactured at Sun Pharmaceutical Industries (SPIL)'s Halol facility. SPIL is working with USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures.

Sun Pharmaceutical Industries' consolidated net profit dropped 60.2% to Rs 478.96 crore on 3.3% growth in net sales to Rs 6522.16 crore in Q1 June 2015 over Q1 June 2014.

Sun Pharmaceutical Industries manufactures specialty and generic medicines, targeting a wide spectrum of chronic and acute treatments. The therapeutic segments include psychiatry, anti-infectives, neurology, cardiology, orthopaedic, diabetology, gastroenterology, ophthalmology, nephrology, urology, dermatology, gynaecology, respiratory, oncology, dental and nutritionals.

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