Aleor Dermaceuticals receives USFDA Tentative Approval for Metronidazole Gel USP, 1% equitybulls.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from equitybulls.com Daily Mail and Mail on Sunday newspapers.
Alembic Pharmaceuticals (Alembic) today announced that its 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 % is indicated for Indicated for the topical treatment of inflammatory lesions of rosacea.
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Alembic Pharmaceuticals rose 1.67% to Rs 999.40 after the company s consolidated net profit jumped 12% to Rs 251 crore on 6% increase in net sales to Rs 1,280 crore in Q4 FY21 over Q4 FY20.On a consolidated basis, the company s net profit jumped 42% to Rs 1178 crore on 17% increase in net sales to Rs 5393 crore in the year ended March 2021 over the year ended March 2020.
International formulations jumped 19% Y-o-Y (year-on-year) to Rs 2,942 crore in FY21 over FY20. US Generics spurted 9% Y-o-Y to Rs 2,163 crore in FY21 over FY20. Ex-US International Formulations soared 57% Y-o-Y to Rs 779 crore in FY21.
13 ANDA s were filed in the quarter and 29 ANDA filings for the year. Research & Department (R&D) spend was reported at 12% of revenue or Rs 670 crore for the year.