Alembic Pharmaceuticals’ joint venture gets USFDA’s tentative approval for Metronidazole Gel

04 May 2021

Alembic Pharmaceuticals’ (Alembic) joint venture Aleor Dermaceuticals (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Metronidazole Gel USP, 1%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Metrogel Gel, 1 %, of Galderma Laboratories LP (Galderma).

Metronidazole Gel USP, 1% has an estimated market size of $32 million for twelve months ending December 2020 according to IQVIA.

Alembic has a cumulative total of 142 ANDA approvals (124 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.

Related Alembic Pharmaceuticals Ltd. Links:

Alembic Pharma Share Price

938.55 -12.35 (-1.30%) May 14, 18:01
1 Year Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 691.10
Dr. Reddys Lab 5195.85
Lupin 1178.80
Piramal Enterprises 1633.00
Cadila Healthcare 617.10
View more..
Sensex vs Alembic Pharma
Puchho Befikar
SEBI Registered: Investment Adviser - INA000013323

Callback