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Results For "Food-and-Drug-Administration"

1018 News Found

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules
Drug Approval | August 31, 2023

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules

Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR


Lupin receives approval from USFDA for Pirfenidone Tablets
Drug Approval | August 28, 2023

Lupin receives approval from USFDA for Pirfenidone Tablets

This product will be manufactured at Lupin's Pithampur facility in India


Gland Pharma receives 2 observations under 483 for Pashamylaram facility
News | August 28, 2023

Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time


Zydus receives final approval from the USFDA for zinc sulfate injection pharmacy bulk package vials
Drug Approval | August 25, 2023

Zydus receives final approval from the USFDA for zinc sulfate injection pharmacy bulk package vials

Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition


Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets
News | August 23, 2023

Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets

Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive


Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences
News | August 23, 2023

Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences

Eris Lifesciences enters into term loan agreement with Citi Bank


Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules
Drug Approval | August 22, 2023

Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules

Oteseconazole Capsules were found to be safe and more effective than fluconazole


Lupin receives approval from USFDA for Bromfenac Ophthalmic
News | August 20, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).


Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations
Drug Approval | August 16, 2023

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.