The company has a cumulative total of 80 ANDA approvals (67 final approvals and 13 tentative approvals) from USFDA.
Shares of Alembic Pharmaceuticals gained 3.4 percent intraday Tuesday after company received USFDA approval.
The company has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Temazepam Capsules USP 7.5mg, 15mg, 22.5mg and 40mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Restoril Capsules, 7.5mg, 15mg, 22.5mg and 40mg, of SpecGx LLC.
Temazepam Capsules are indicated for short term treatment of insomnia.
Temazepam Capsules have an estimated market size of USD 48 million for 12 months ending December 2017, according to IQVIA.
The company has a cumulative total of 80 ANDA approvals (67 final approvals and 13 tentative approvals) from USFDA.
At 10:55 hrs Alembic Pharmaceuticals was quoting at Rs 568.25, up Rs 8.70, or 1.55 percent.
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