Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Treprostinil Injection, 20 mg/20 ml (1 mg/ml), 50 mg/20 ml (2.5 mg/ml), 100 mg/20 ml (5 mg/ml), and 200 mg/20 ml(1 O mg/ml), Multiple-Dose Vials. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RlD), Remodulin Injection, 20 mg/20 ml (1 mg/ml), 50 mg/20 ml (2.5 mg/ml), 100 mg/20 ml (5 mg/ml), and 200 mg/20 ml (10mg/ml), of United Therapeutics Corp. (United). Treprostinil Injection is indicated for thetreatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise.

Treprostinil Injection has an estimated market size of US$ 466.1 million for twelve monthsending Dec. 2019 according to United Therapeutics Corporation's 2019 financial results.

Alembic now has a total of 131 ANDA approvals (113 final approvals and 18 tentativeapprovals) from USFDA.

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Alembic Pharmaceuticals announced that the tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Glyxambi tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer).

Empagliflozin and Linagliptin tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Empagliflozin and Linagliptin is appropriate. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. However, the effectiveness of Empagliflozin and Linagliptin tablets on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established.

Empagliflozin and Linagliptin tablets, 10 mg/5 mg and 25 mg/5 mg have an estimated market size of $244 million for twelve months ending June 2020 according to IQVIA. Alembic is currently in litigation with Boehringer in District Court of Delaware and launch of theproduct will depend on litigation outcome.

Alembic Pharmaceuticals reported a 143.7% surge in consolidated net profit to Rs 301.46 crore on 41.4% rise in net sales to Rs 1,341.32 crore in Q1 June 2020 over Q1 June 2019.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

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Alembic Pharmaceuticals announced that it has received tentativeapproval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Glyxambi Tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer IngelheimPharmaceuticals, Inc. (Boehringer). Empagliflozin and Linagliptin Tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Empagliflozin and Linagliptin is appropriate. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. However, the effectiveness of Empagliflozin and Linagliptin Tablets on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established.

Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg have an estimated market size of US$ 244 million for twelve months ending June 2020 according to IQVIA. Alembic is currently in litigation with Boehringer in District Court of Delaware and launch of the productwill depend on litigation outcome.

Alembic now has a total of 130 ANDA approvals (113 final approvals and 17 tentative approvals) from USFDA.

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Alembic Pharmaceuticals announced that its joint venture AleorDermaceuticals has received final approval from the US Food & DrugAdministration (USFDA) for its Abbreviated New Drug Application (ANDA) for Desonide Lotion, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), DesOwen® Lotion, 0.05% of Galderma Laboratories LP. Desonide Lotion is low to medium potency corticosteroids indicated for the relief of the Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Desonide Lotion, 0.05% has an estimated market size of US$ 7 million for twelve monthsending June 2020 according to IQVIA.

Alembic has a cumulative total of 129 ANDA approvals (113 final approvals and 16 tentativeapprovals) from USFDA.

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