Alembic Pharma bags USFDA final nod for orthostatic hypotension tablets
January 22, 2021
Alembic Pharmaceuticals R&D BioEquivalance Centre at Vadodara in Gujarat×
Alembic Pharmaceuticals Limited has received the US drug regulator- US Food & Drug Administration (USFDA) s approval for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg,5 mg, and 10 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine Tablets, 2.5 mg, 5 mg, and 10 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda).
Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).
Midodrine Hydrochloride Tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size of USD 60 million for twelve months ending September 2020, according to IQVIA.
Alembic Pharma Q3 standalone net up 19% at ₹277 crore
January 19, 2021
Formulations business grows 3% in international markets, 14% in domestic market Pharma player Alembic Pharmaceuticals Limited on Tuesday posted standalone net profit at ₹277 crore for the quarter ended December 31, 2020, which is about 19 per cent higher than ₹233 crore reported in the corresponding quarter last year.
The company’s standalone revenues from operations stood at ₹1,236 crore for the quarter as against ₹1,052 crore in the same period last year.
On a consolidated basis, the company posted net profit of ₹293 crore for the quarter ended December 2020, which is about 25 per cent higher than ₹234 crore reported in the corresponding quarter last year.
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