Alembic's subsidiary receives USFDA for Glycopyrrolate & Candesartan Cilexetile

Alembic Pharmaceuticals Ltd. has announced that its wholly-owned subsidiary, Orit Laboratories LLC, has received approval from the USFDA for its Abbreviated New Drug Application (ANDA) Glycopyrrolate Tablets USP, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Robinul and Robinul Forte Tablets, 1 mg and 2 mg, of Casper Pharma LLC.

Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcers. The drug has an estimated market size of $15-mn for 12 months ending December 2017, according to IQVIA.

Approval for Candesartan Cilexetil Tablets

In another development, Alembic announced that it has also received approval from the USFDA for its ANDA Candesartan cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg. The approved ANDA is therapeutically equivalent to the RLD, Atacand Tablets, 4 mg, 8 mg, and 16 mg, of ANI Pharmaceuticals, Irie.

Candesartan Cilexetil Tablets are indicated for the treatment of hypertension in adults and in children (1-17 years of age), to lower blood pressure. They are also indicated for the treatment of heart failure. The drug has an estimated market size of $22-mn for the 12 months ending December 2017, according to IQVIA.