Search For "us food and drug administration us fda"
US FDA inspects Vishakhapatnam facility of Solara Active Pharma
Updated : 1 year, 10 months ago IST
US Food and Drug Administration (US FDA) has successfully completed the inspection of the multipurpose API manufacturing facility of Solara Active Pharma Sciences Limited (Solara) at Visakhapatnam, Andhra Pradesh.
Read More
Sun Pharma, SPARC sign licence agreement for sale of seizure drug for inje
Updated : 3 years, 4 months ago IST
SPARC submitted a new drug application (NDA) to the US Food and Drug Administration (US FDA) for this product for the treatment of seizures in newborns in February 2022, according to Sun Pharma statement shared with stock exchanges.
Read More
Indian pharma compliance standards improving, regulatory risks here to sta
Updated : 5 years, 8 months ago IST
Mumbai (Maharashtra) [India], July 7 (ANI): Indian pharmaceutical companies have built a strong abbreviated new drug application (ANDA) pipeline since FY12 through scaling-up of investments in R&D but this will increase the inspection intensity, India Ratings and Research (Ind-Ra) said o
Read More
US FDA issues warning letter for Glenmark Pharmaceuticals facility in Badd
Updated : 6 years, 5 months ago IST
Mumbai (Maharashtra) [India], Oct 7 (ANI): The US Food and Drug Administration (US FDA) has issued a warning letter to Glenmark Pharmaceuticals for breach of norms at its facility at Baddi in Himachal Pradesh.
Read More
US FDA issues warning letter for Lupin's Mandideep facility
Updated : 6 years, 6 months ago IST
Mumbai (Maharashtra) [India], Sep 19 (ANI): The US Food and Drug Administration (US FDA) has issued a warning letter to pharma major Lupin Ltd for its facility at Mandideep in Madhya Pradesh.
Read More