Alembic Pharmaceuticals gains on getting USFDA’s approval for Glycopyrrolate Injection

01 Nov 2022 Evaluate

Alembic Pharmaceuticals is currently trading at Rs. 553.30, up by 3.35 points or 0.61% from its previous closing of Rs. 549.95 on the BSE.

The scrip opened at Rs. 552.70 and has touched a high and low of Rs. 557.95 and Rs. 550.00 respectively. So far 3408 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 847.95 on 04-Jan-2022 and a 52 week low of Rs. 541.10 on 20-Oct-2022.

Last one week high and low of the scrip stood at Rs. 560.00 and Rs. 542.50 respectively. The current market cap of the company is Rs. 10849.30 crore.

The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.87% and 12.52% respectively.

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Injection USP, 0.2 mg/1 mL and 0.4 mg/2 mL (0.2 mg/mL) Single-dose Vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) Multiple-dose Vials. This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), of Hikma Pharmaceuticals USA Inc. (Hikma). Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.

Glycopyrrolate Injection USP, has an estimated market size of $ 42 million for twelve months ending June 2022 according to IQVIA. Alembic has a cumulative total of 173 ANDA approvals (149 final approvals and 24 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

843.15 -9.15 (-1.07%)
29-Dec-2025 16:59 View Price Chart
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