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

380 News Found

Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals
Drug Approval | March 18, 2023

Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals

Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.


Briefs: Lupin and Alembic
News | March 14, 2023

Briefs: Lupin and Alembic

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.


Zydus receives final approval from the USFDA for Olanzapine
News | March 13, 2023

Zydus receives final approval from the USFDA for Olanzapine

Olanzapine Orally Disintegrating Tablets are used to treat certain mental/mood conditions


USFDA completes inspection of Lupin’s Vizag facility
Drug Approval | March 11, 2023

USFDA completes inspection of Lupin’s Vizag facility

The inspection concluded with no observations


Zydus receives final approval from the USFDA for Erythromycin Tablets
Drug Approval | March 10, 2023

Zydus receives final approval from the USFDA for Erythromycin Tablets

Erythromycin Tablets USP, 250 mg and 500 mg are used to prevent and treat infections in many different parts of the body


Caplin Steriles gets USFDA approval for Thiamine Hydrochloride Injection
Drug Approval | March 09, 2023

Caplin Steriles gets USFDA approval for Thiamine Hydrochloride Injection

Thiamine Hydrochloride Injection is effective in the treatment of vitamin B1 deficiency (beriberi)


Jubilant Pharmova receives VAI from USFDA for its API manufacturing facility
Drug Approval | March 09, 2023

Jubilant Pharmova receives VAI from USFDA for its API manufacturing facility

Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)


Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution
Drug Approval | March 06, 2023

Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution

Vigabatrin for Oral Solution USP, 500 mg had annual sales of US $233.7 mn in US


Caplin Steriles gets USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 04, 2023

Caplin Steriles gets USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection is a neuromuscular blocking agent


Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution
Drug Approval | March 04, 2023

Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution

Vigabatrin for Oral Solution USP, 500 mg had annual sales of USD 233.7 mn in the United States