Alembic Pharmaceuticals surges on getting USFDA’s nod for Asenapine Sublingual Tablets

11 Dec 2020 Evaluate

Alembic Pharmaceuticals is currently trading at Rs. 1079.40, up by 19.10 points or 1.80% from its previous closing of Rs. 1060.30 on the BSE.

The scrip opened at Rs. 1060.30 and has touched a high and low of Rs. 1082.20 and Rs. 1060.30 respectively. So far 4688 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1128.00 on 07-Aug-2020 and a 52 week low of Rs. 436.10 on 23-Mar-2020.

Last one week high and low of the scrip stood at Rs. 1082.20 and Rs. 1011.75 respectively. The current market cap of the company is Rs. 21133.48 crore.

The promoters holding in the company stood at 69.77%, while Institutions and Non-Institutions held 16.46% and 13.76% respectively.

Alembic Pharmaceuticals has received approval from 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 to lithium or valproate in adults.

The company 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 $217 million for twelve months ending September 2020. The company has a cumulative total of 137 ANDA approvals (119 final approvals and 18 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

Alembic Pharma Share Price

899.90 -2.30 (-0.25%)
05-Dec-2025 16:59 View Price Chart
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