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Results For "FDA"

1767 News Found

Eugia Pharma receives USFDA approval for Vasopressin Injection USP
Drug Approval | August 16, 2022

Eugia Pharma receives USFDA approval for Vasopressin Injection USP

The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.


Lupin receives USFDA approval for Meclizine Hydrochloride Tablets USP
Drug Approval | August 13, 2022

Lupin receives USFDA approval for Meclizine Hydrochloride Tablets USP

The product will be manufactured at Lupin’s facility in Goa, India.


Roche gets USFDA approval of Xofluza to treat influenza in children
Drug Approval | August 13, 2022

Roche gets USFDA approval of Xofluza to treat influenza in children

Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age


Zydus receives final approval from the USFDA for Ivermectin Cream
Drug Approval | August 04, 2022

Zydus receives final approval from the USFDA for Ivermectin Cream

Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.


Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee
News | August 03, 2022

Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee

he US FDA has issued six observations pursuant to the completion of the audit.


USFDA issues 3 observations for Aurobindo Pharma’s Unit XI
Drug Approval | August 03, 2022

USFDA issues 3 observations for Aurobindo Pharma’s Unit XI

The company has responded to the warning letter and carried out the committed corrections.


Strides receives USFDA approval for Cyclosporine Softgel Capsules
Drug Approval | August 03, 2022

Strides receives USFDA approval for Cyclosporine Softgel Capsules

Strides is the first Indian company to get approval for the product.


Casper Pharma completed USFDA pre-approval inspection
Drug Approval | July 31, 2022

Casper Pharma completed USFDA pre-approval inspection

The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.


Shilpa Medicare's Unit III, Advanced Analytical Characterization Laboratory clears US FDA remote record review
Drug Approval | July 31, 2022

Shilpa Medicare's Unit III, Advanced Analytical Characterization Laboratory clears US FDA remote record review

The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing


Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets
Drug Approval | July 26, 2022

Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.