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1 min read
USFDA completes inspection of Cipla's API manufacturing unit
New Delhi, Jan 24 () Pharmaceutical firm Cipla on Friday said the US Food and Drug Administration h…
PTI
1 min read
Cipla gets USFDA observations for its Goa facility
New Delhi, Jan 22 () Drug firm Cipla on Wednesday said it has received observations from the USFDA …
PTI
1 min read
Strides gets USFDA nod for anti-allergic drug
New Delhi, Jan 16 () Strides Pharma Science on Thursday said it has received approval from the US h…
PTI
1 min read
Glenmark gets USFDA's final nod for Deferasirox tablets
New Delhi, Jan 7 () Glenmark Pharmaceuticals on Tuesday said it has got final approval from the US …
PTI
1 min read
Lupin gets USFDA establishment inspection report for Aurangabad unit
The inspection for the facility was carried out by the US Food and Drug Administration (USFDA) bet…
PTI
1 min read
Biocon gets EIR from USFDA for manufacturing facility in Bengaluru
"Biocon has received the EIR from the US Food and Drug Administration (FDA) for the post-approval …
PTI
1 min read
Alkem Labs gets EIR from USFDA for Baddi facility
The Baddi facility was inspected by the United States Food and Drug Administration (USFDA) from Fe…
PTI
1 min read
USFDA accepts proposed biosimilar application by Mylan, Biocon for review
The application seeks approval of Bevacizumab for the first-line and second-line treatment of pati…
PTI
1 min read
US health regulator issues warning letter to Cipla for Goa manufacturing facility inspection
Drug firm Cipla Ltd on Wednesday said that the US health regulator has issued a warning letter to t…
PTI
1 min read
USFDA issues warning letter to Cipla for Goa manufacturing facility
"Further to our earlier communication on the Goa manufacturing facility inspection conducted from …
PTI
1 min read
USFDA inspection of Unichem Lab's Roha facility completed with no observation
As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when in…
PTI
1 min read
Biocon gets 3 USFDA observations for insulin facility in Malaysia
As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when in…
PTI
1 min read
Alkem Labs gets 2 USFDA observations for Baddi facility
As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when an …
PTI
1 min read
USFDA rescinds VAI status for Aurobindo Pharma's Hyderabad unit
The company has received a communication that the inspection conducted by the US Food and Drug Adm…
PTI
1 min read
USFDA seeks voluntary action at Dr Reddy's Duvvada facility
"With regard to the audit of our Formulations Manufacturing Plant at Duvvada, Visakhapatnam, we wou…
PTI
1 min read
Zydus Cadila gets USFDA nod to market Mesalamine suppositories
Mesalamine Suppositories is an aminosalicylate anti-inflammatory drug and is believed to work by b…
PTI
1 min read
Zydus Cadila gets USFDA nod to market ointment for treating skin conditions
The company has received final approval from the United States Food and Drug Administration (USFDA…
PTI
1 min read
Granules Pharmaceuticals, Inc gets USFDA nod for Colchicine tablets
"The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (…
PTI
2 mins read
ICMR experts reject inclusion of Molnupiravir in COVID-19 treatment guidelines for fourth time citing safety concerns
Responding to a question over Molnupiravir's inclusion in the treatment guidelines amid doctors …
PTI
1 min read
Granules India gets USFDA nod for overactive bladder treatment capsule
"The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application fil…