Alembic Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 19 January 2021.

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Alembic Pharmaceuticals announced it has received approvalfrom the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Saphris Sublingual Tablets, 5 mg and 10 mg, of Allergan Sales, LLC (Allergan). Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment tolithium or valproate in adults.

Alembic had previously received tentative approval for this ANDA. Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity.

Asenapine Sublingual Tablets, 5 mg and 10 mg have an estimated market size of US$217 million for twelve months ending September 2020 according to IQVIA.

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The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Zaroxolyn tablets 2.5 mg, 5 mg, and 10 mg, of Lannett Company, Inc.

The drug is indicated for treating salt and water retention including edema accompanying congestive heart failure; edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. It is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.

Metolazone tablets have an estimated market size of $33 million for twelve months ending September 2020 according to IQVIA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It has a cumulative total of 137 ANDA approvals (118 final approvals and 19 tentative approvals) from US Food & Drug Administration (USFDA).

Alembic Pharma reported a 35.4% jump in consolidated net profit to Rs 333.37 crore on 17.4% rise in net sales to Rs 1,457.10 crore in Q2 September 2020 over Q2 September 2019.

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Alembic Pharmaceuticals announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg. Theapproved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Zaroxolyn Tablets 2.5 mg, 5 mg, and 10 mg, of Lan nett Company, Inc. Metolazone Tablets are indicated for the treatment of salt and water retention including: a) edema accompanying congestive heart failure; b) edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone Tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.

Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size ofUS$ 33 million for twelve months ending September 2020 according to IQVIA.

Alembic has a cumulative total of 137 ANDA approvals (118 final approvals and 19tentative approvals) from USFDA.

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