1. Cadila shares soar over 10% after USFDA final approval to market Lialda in US

Cadila shares soar over 10% after USFDA final approval to market Lialda in US

Share prices of Cadila Healthcare soared about 10.30% to Rs 540 on the NSE on the back of reports that the drug maker has received the final approval from USFDA to market its Mesalamine Delayed-Release Tablets in the US market.

By: | Published: June 7, 2017 10:43 AM
Cadila Healthcare was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda and hence will be eligible for an 180 days exclusivity. (Website)

Share prices of Cadila Healthcare soared about 10.30% to Rs 540 on the NSE on the back of reports that the drug maker has received the final approval from the United States Food and Drug Administration (USFDA) to market its Mesalamine Delayed-Release Tablets in the US market, as per ET Now. Cadila Healthcare was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda and hence will be eligible for an 180 days exclusivity.

Lialda is indicated for the treatment of mild to moderate ulcerative colitis. Ulcerative colitis is a chronic inflammatory bowel disease that affects approximately 700,000 people in the United States. The generic version of Lialda, called Mesalamine, will be produced at the company’s Moraiya plant located in Ahmedabad, which is yet to get a formal EIR from USFDA. The drug maker expects to start shipping Lialda from Moraiya facility starting July or August. The group now has more than 115 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.

Monday, the company had reported that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its manufacturing facility at Baddi, Himachal Pradesh. USFDA had earlier given three observations under Form 483 after inspection of the facility.

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“The company’s manufacturing facility at Baddi has received an Establishment Inspection Report from the USFDA”, Cadila Healthcare said in a BSE filing on 5 June. This receipt of EIR indicates successful closure of the 483s raised based on the inspection carried out between February 21 to March 1, 2017, the statement added. All the observations were related to pre-approval inspection (PAI) for a specific product filed, Cadila Healthcare had then said without naming the product.

For the quarter ended March 31, 2017, Cadila Healthcare reported a net profit of Rs 385.50 crore, down 32.15 per cent from Rs 568.20 crore in the corresponding quarter last year. Net sales of the company jumped 6.48 percent year-on-year to Rs 2417.50 crore for the quarter under review. The company had reported net sales of Rs 2270.30 crore in the same period a year ago.

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