The company will be submitting the responses to US FDA observations within stipulated timeline
The inspection concluded with no observations
Erythromycin Tablets USP, 250 mg and 500 mg are used to prevent and treat infections in many different parts of the body
Prazosin Hydrochloride Capsule is indicated for the treatment of hypertension, to lower blood pressure
The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone
Thiamine Hydrochloride Injection is effective in the treatment of vitamin B1 deficiency (beriberi)
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum and breast
With this additional route of administration, the MMRV Family now joins other routinely recommended vaccines that can be administered intramuscularly
Vigabatrin for Oral Solution USP, 500 mg had annual sales of US $233.7 mn in US
Rocuronium Bromide Injection is a neuromuscular blocking agent
Vigabatrin for Oral Solution USP, 500 mg had annual sales of USD 233.7 mn in the United States
he product will be launched shortly in the US market.
Apixaban Tablets, 2.5 mg and 5 mg had annual sales of USD 18,876 mn in the United States (IQVIA MAT Dec. 2022).
This combination medicine is used to treat high blood pressure (hypertension).
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
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.
The British-Swedish pharma major certainly has a strong competitive edge for BTC treatment in the country
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