Halol's non-compliance has held up fresh product approvals from the site for nearly four years, and is partly responsible for the muted growth in the US for Sun.
Markets trade flat, Sun Pharma advances
The stock was trading 2% higher at Rs 587 on the BSE in otherwise subdued market, trading nears to 52-week high of Rs 609 touched on February 12, 2018.
The drug maker has guided for an increase in R&D expenses in FY 19 as it builds a pipeline of specialty products
At 03:16 pm; the Nifty Pharma index, the sole gainer among sectoral indices, was up 2%, as compared to 0.49% decline in Nifty 50 index.
The stock was up 4% to Rs 561 on BSE in early morning trade, extending its past five days 14% rally, after the company announced the resolution of regulatory compliance issues at Halol plant.
While the plant was served warning letter by US regulator in December 2015, product approvals were frozen in September 2014
The Halol plant was reinspected by the FDA in the March quarter, and had received three Form 483 observations
The stock rallied 6% to Rs 496 on the BSE in early morning trade after the drug maker reported a net profit of Rs 13.08 billion in March 2018 quarter.
While the company, which derives 35 per cent of its consolidated sales from the US market, reported a 3 per cent fall over the year-ago quarter
The company expects revenue growth on the back of three speciality drug launches in US and growth across markets
The company had reported a net profit of Rs 12.23 billion in the same period of the previous financial year.
Sales of acne drug Absorica were down 26 per cent on a sequential basis in the March quarter
Marksans Pharma, Ajanta Pharma, Morepen Lab, Alkem Laboratories, SPARC and Aarti Drugs were down in the range 3% to 4% on the BSE.
Given pricing pressure in the US on its generic portfolio, Sun Pharma has been focusing on bringing to the market its next growth vehicle in the form of speciality drugs
The stock was trading 2% higher at Rs 515 as compared to a marginal 0.05% gain in the S&P BSE Sensex at 09:17 am.
The market for psoriasis drugs in US is over $ 6 billion and the approval allows the drugmaker to expand its portfolio in dermatology space
Dilip Shanghvi cited the example of auto components manufacturer Motherson Sumi, which has only 2% attrition rate
Down from 9 it received in December 2016
The stock was up 3.5% at Rs 561 on the BSE at 02:34 pm, after the company said the USFDA issued Form 483, with three observations, for its Halol facility in Gujarat.