Drug Approval | March 21, 2023
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)
Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)
The observations are procedural in nature
Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.
Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.
Olanzapine Orally Disintegrating Tablets are used to treat certain mental/mood conditions
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
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)
Vigabatrin for Oral Solution USP, 500 mg had annual sales of US $233.7 mn in US
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