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).

Alembic gets USFDA final approval for ANDA Docetaxel Injection

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi

The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region

Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.

Biliary tract cancer drug Durvalumab approval key opportunity for AstraZeneca in India, says GlobalData

The British-Swedish pharma major certainly has a strong competitive edge for BTC treatment in the country

Strides flagship facility in Bangalore receives USFDA inspection closure

Zydus receives final approval from the USFDA for Pitavastatin Tablets

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma