Granules says USFDA audit of Visakhapatnam facility resulted in zero 483 observations
Upstox
2 min read • Updated: April 15, 2024, 11:50 AM
Summary
Granules said the facility underwent an inspection by the United States Food and Drug Administration (USFDA) from April 8 to April 12. This audit was a pre-approval inspection (PAI) and current good manufacturing practices (cGMP) audit for active pharmaceutical ingredients (APIs) and formulations. The facility manufactures APIs and formulations of oncology and non-oncology products.
Pharma company Granules India notified to the stock exchanges that the company’s Unit V facility located at Anakapally in Visakhapatnam, Andhra Pradesh underwent an inspection by the United States Food and Drug Administration (USFDA) from April 8 to April 12 with the audit resulting in zero 483s.
This audit was a pre-approval inspection (PAI) and current good manufacturing practices (cGMP) audit for active pharmaceutical ingredients (APIs) and formulations, the company said. The facility manufactures APIs and formulations of oncology and non-oncology products. Shares of the company were down over 1% on Monday morning.
The company had recently stated that its wholly-owned foreign subsidiary Granules Pharmaceuticals, Inc. (GPI), located in Chantilly, Virginia, USA had received a communication from the USFDA indicating the inspection classification as “Voluntary Action Indicated” (VAI). The VAI inspection classification indicates that the USFDA will not take or recommend regulatory or enforcement action because the observations do not meet the threshold for action at this time, it had said.
During the third quarter of fiscal year 2024, Granules reported revenue from operations at ₹1,155.6 crore, registering a growth of 1% year-over-year (y-o-y) and a decline of 3% quarter-over-quarter (q-o-q). Earnings before interest, tax, depreciation and amortisation (EBITDA) grew 8% y-o-y to ₹250.50 crore while EBITDA margin improved to 22% from 20% a year ago. Net profit during the quarter grew 1% y-o-y to ₹125.7 crore. Granules had said its net debt stood at ₹928.5 crore.
API, Pharmaceutical Formulation Intermediates (PFI), and finished dosages contributed 19%, 15%, and 66% of revenue from operations respectively for Q3FY24, the company said. The focus on formulations sales has increased resulting in the momentum shifting from API and PFI to formulations, it added.
Shares of the company have gained over 1% since the beginning of the year. The stock has risen over 41% in the last one year.