Cadila Healthcare Ltd has become India’s second-most valuable pharmaceutical company in terms of market capitalisation, leaving behind drug maker rivals like Lupin Ltd, Dr Reddy’s Laboratories Ltd and Cipla Ltd that have much higher revenues.
The share prices of Cadila Healthcare climbed about 10.30% to Rs 540 on the NSE because of reports that the drug maker has obtained the final approval from the United States Food and Drug Administration (USFDA) to sell its Mesalamine Delayed-Release Tablets in the US market.
Cadila Healthcare was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda and so now will be suitable for a 180 days exclusivity.
Lialda is used to treat mild to moderate ulcerative colitis. Ulcerative colitis is a chronic inflammatory bowel disease that affects around 700,000 people in the United States.
The generic version of Lialda, called Mesalamine, will be manufactured at the company’s Moraiya plant located in Ahmedabad, which however has not yet obtained 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 till now over 300 ANDAs since the start of the categorising process in FY 2003-04.
Monday, the company had stated that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its manufacturing plant at Baddi, Himachal Pradesh. USFDA had earlier presented three observations under Form 483 after inspection of the facility.
“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 approval of EIR indicates successful closure of the 483s raised based on the inspection carried out from 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 quadrant 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 spiked up 6.48 percent year-on-year to Rs 2417.50 crore for the quarter under consideration. The company had reported net sales of Rs 2270.30 crore in the same period a year ago.