Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)

Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit

The observations are procedural in nature

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.

Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP

Cleocin Hydrochloride Capsules market achieved annual sales of approximately US $33.6 million

Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division

The company will be submitting the responses to US FDA observations within stipulated timeline

USFDA completes inspection of Lupin’s Vizag facility

The inspection concluded with no observations

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

Alembic receives USFDA tentative approval for Brexpiprazole Tablets

Alembic receives USFDA final approval for Prazosin Hydrochloride Capsules

Prazosin Hydrochloride Capsule is indicated for the treatment of hypertension, to lower blood pressure

Eugia Pharma receives USFDA approval for Lenalidomide Capsules

The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone

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

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

Alembic Pharmaceuticals gets USFDA final approval for fluorouracil injection

Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum and breast

USFDA approves intramuscular administration for Merck’s MMRV family of vaccines

With this additional route of administration, the MMRV Family now joins other routinely recommended vaccines that can be administered intramuscularly

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

Rocuronium Bromide Injection is a neuromuscular blocking agent

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

Zydus receives final approval from the USFDA for Acyclovir Cream

he product will be launched shortly in the US market.

Zydus receives final approval from the USFDA for Apixaban Tablets

Apixaban Tablets, 2.5 mg and 5 mg had annual sales of USD 18,876 mn in the United States (IQVIA MAT Dec. 2022).

Zydus receives final approval from the USFDA for Hydrochlorothiazide Tablets

This combination medicine is used to treat high blood pressure (hypertension).