 "US FDA issues warning letter for Divi's Laboratories' Visakhapatnam unit")
The Hyderabad-based active pharmaceutical ingredients (APIs) maker Divi's Laboratories has received a warning letter from the US Food & Drug Administration (FDA) for the company's Unit-II at Visakhapatnam.
Earlier, the US FDA had issued an import alert on March 20, 2017 on the products manufactured at the company's Unit-II at Visakhapatnam, Andhra Pradesh. However, the US drug regulator had exempted products such as levetiracetam, gabapentin, lamotrigine, capecitabine, naproxen sodium, raltegravir potassium, atovaquone, chloropurine, BOC core succinate and 2,4-wing active ester from the import alert.
“In the Import Alert issued, US-FDA has exempted several products manufactured at the company's Unit-II at Visakhapatnam, Andhra Pradesh. We will continue to supply these active ingredients to meet its obligations to our customers,” said the company in a BSE filing on Saturday.
Divi's Labs added that the company, along with external consultants and subject matter experts, was working to address the concerns of the US FDA and was making all efforts to fully meet the compliance requirements. “We will respond to this warning letter with a detailed plan within the stipulated time,” it said.
To read the full story, Subscribe Now at just Rs 249 a month
Already a subscriber? Log in
Subscribe To BS Premium
MONTHLY₹8/day
₹249
Renews automatically
SMART ANNUAL₹5/day
₹1699₹1999
Opt for auto renewal and save Rs. 300 Renews automatically
ANNUAL₹6/day
₹1999
What you get on BS Premium?
-
Unlock 30+ premium stories daily hand-picked by our editors, across devices on browser and app. -
Pick your 5 favourite companies, get a daily email with all news updates on them. '%3E%3Cg id='Artboard-Copy' transform='translate(0 0.012)'%3E%3Cg id='_126115' transform='translate(0 0)'%3E%3Cpath id='Path' d='M17.537 1.487a.473.473 0 0 0-.467.477v12.67A2.4 2.4 0 0 1 14.7 17.06H3.3A2.4 2.4 0 0 1 .933 14.634V.966H14.587v12.29a.467.467 0 0 0 .933 0V.489a.473.473 0 0 0-.467-.477H.467A.473.473 0 0 0 0 .489V14.63a3.346 3.346 0 0 0 3.3 3.382H14.7A3.346 3.346 0 0 0 18 14.63V1.965a.467.467 0 0 0-.462-.478Z' transform='translate(0 -0.012)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-2' d='M12.676 3.955a.478.478 0 1 0 0-.955H2.508a.478.478 0 1 0 0 .955Z' transform='translate(0.124 0.166)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-3' d='M12.676 13H2.508a.478.478 0 1 0 0 .955H12.672a.478.478 0 1 0 0-.955Z' transform='translate(0.124 0.768)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Shape' d='M2 6v5.371a.484.484 0 0 0 .467.5H7.531a.484.484 0 0 0 .467-.5V6a.484.484 0 0 0-.467-.5H2.467A.484.484 0 0 0 2 6Zm.933.5H7.066v4.375H2.933Z' transform='translate(0.122 0.317)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-4' d='M12.321 5.5H8.967a.478.478 0 1 0 0 .955h3.354a.478.478 0 1 0 0-.955Z' transform='translate(0.517 0.317)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-5' d='M12.321 8H8.967a.478.478 0 1 0 0 .955h3.354a.478.478 0 1 0 0-.955Z' transform='translate(0.517 0.467)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-6' d='M12.788 10.977a.473.473 0 0 0-.467-.477H8.967a.478.478 0 1 0 0 .955h3.354a.471.471 0 0 0 .467-.478Z' transform='translate(0.517 0.617)' fill='%23c4132a'%3E%3C/path%3E%3C/g%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Full access to our intuitive epaper - clip, save, share articles from any device; newspaper archives from 2006.
Preferential invites to Business Standard events.
Curated newsletters on markets, personal finance, policy & politics, start-ups, technology, and more.
Need More Information - write to us at assist@bsmail.in