ANI Pharmaceuticals exceeded Q1 Non-GAAP earnings expectations and raised its guidance to $385-$410 million. See why I rate ANIP stock a Strong Buy here.
The drug maker received a final approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride and timolol maleate ophthalmic solution.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cosopt Ophthalmic Solution, 2% and 0.5% of Akorn Operating Company.
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor blocking agent, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
As per IQVIA, dorzolamide hydrochloride and tirnolol maleate ophthalmic solution USP, 2% and 0.5% has an estimated market size of $80 million for twelve months ending December 2020.
Alembic Pharmaceuticals gained 0.59% to Rs 956.4 after the drug maker received the US drug regulator s approval for midodrine hydrochloride tablets.Alembic Pharmaceuticals (Alembic) on 22 January 2020 announced that it received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) midodrine hydrochloride tablets USP, 2.5 mg, 5 mg, and 10 mg. The drug is indicated for the treatment of symptomatic orthostatic hypotension (OH).
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine tablets of Takeda Pharmaceuticals USA, Inc. (Takeda).
Midodrine hydrochloride tablets have an estimated market size of $60 million for twelve months ending September 2020 according to IQVIA.
The drug maker reported 25% jump in consolidated net profit to Rs 293 crore on a 9% rise in net sales to Rs 1314 crore in Q3 FY21 over Q3 FY20.
The company s international formulations business grew 3% year-on-year (YoY) to Rs 683 crore while the ex-US international formulations business grew 14% YoY to Rs 171 crores in the quarter. The firm received 8 ANDA approvals received during the quarter taking the cumulative to 137 ANDA approvals.
During Q3 FY21, Alembic s India formulations business grew 14% YoY to Rs 418 crore with specialty segments growing by 16%, led by cardio, diabeto, gyanaec and gastro segments.
API business grew 21 %to Rs 214 crores in Q3 December 2020 over Q3 December 2019. The company filed 4 drug master files (DMF) taking the cumulative to 115 DMFs.