Aarti Drugs receives five observations in Form 483 from USFDA for its Himachal Pradesh facility
Upstox
2 min read • Updated: April 23, 2024, 2:44 PM
Summary
Aarti Drugs said the company will work closely with USFDA in resolving all points. However, there is no impact on financial, operation or other activities of the company following the observations received, it stated. Shares of the company were trading 0.86% higher on Tuesday.
Aarti Drugs said in an exchange filing that the company has received five observations in Form 483 from the United States Food and Drug Administration after the agency inspected the formulations manufacturing facility of the company’s subsidiary Pinnacle Life Science at Baddi, Himachal Pradesh.
The inspection was carried out from April 16 to 22nd, the company said.
“On conclusion of the inspection, the company has received 5 inspectional observations in Form 483, where none of the observations are related to data integrity. The company will work closely with USFDA in resolving all points. There is no impact on financial, operation or other activities of the company pursuant the observations received,” it said.
Shares of the company were trading 0.86% higher on Tuesday.
Aarti Drugs is a Mumbai-based diversified and fully integrated pharmaceutical company, with interests in active pharmaceutical ingredients (API), formulation, specialty chemicals and intermediates. The company had recently announced commencement of production of its dermatology product at new facility at Tarapur, Maharashtra.
The new facility is located adjacent to its existing manufacturing units, the company said adding that the strategic expansion aligns with its vision to strengthen its presence in the skincare segment.
The total investment requirement amounted between ₹150 to ₹200 crore to complete setting up this facility, partially financed through term loan and internal accruals, it had said.
For the third quarter of fiscal year 2024, Aarti Drugs reported 8.6% year-over-year (y-o-y) drop in its revenue at ₹607.6 crore. Earnings before interest, tax, depreciation and amortisation (EBITDA) and net profit came in flat at ₹71.8 crore and ₹36.7 crore, respectively, during the quarter.
The formulations segment saw its revenues shoot up by 59% y-o-y to ₹79.3 crore during the quarter.
Shares of Aarti Drugs gained 0.46% since the beginning of the year. The stock has risen over 18% in the last one year.