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Results For "United-States-Food-and-Drug-Administration"

395 News Found

Zydus gets USFDA’s approval for Empagliflozin, Metformin Hydrochloride tablets
Drug Approval | July 12, 2022

Zydus gets USFDA’s approval for Empagliflozin, Metformin Hydrochloride tablets

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.


Lupin’s Somerset manufacturing plant Receives EIR from US FDA
Drug Approval | July 08, 2022

Lupin’s Somerset manufacturing plant Receives EIR from US FDA

The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


Cipla updates on US FDA product-specific pre-approval inspection
News | July 06, 2022

Cipla updates on US FDA product-specific pre-approval inspection

The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.


Lupin receives approval from USFDA for Paliperidone extended-release tablets
Drug Approval | July 01, 2022

Lupin receives approval from USFDA for Paliperidone extended-release tablets

Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S


Zydus receives final approval from USFDA for Lacosamide injection
Drug Approval | July 01, 2022

Zydus receives final approval from USFDA for Lacosamide injection

Lacosamide Injection is used to treat partial-onset seizures.


Lupin receives tentative approval from FDA for Ivacaftor tablets
Drug Approval | June 08, 2022

Lupin receives tentative approval from FDA for Ivacaftor tablets

Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.


Zydus Lifesciences receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel
Drug Approval | June 07, 2022

Zydus Lifesciences receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel

The drug will be manufactured at the group’s topical facility at Ahmedabad


Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod
Biotech | May 29, 2022

Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod

The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs


Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection
Drug Approval | May 26, 2022

Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection

Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)


Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII
News | May 11, 2022

Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII

The unit is an oral manufacturing facility at Jedcherla, Hyderabad