Aleor Dermaceuticals

USFDA approves antifungal cream of Aleor

Aleor Dermaceuticals, a joint venture of Alembic Pharma gets the USFDA approval for its generic antifungal cream :

On 1 April 2021, Alembic Pharma made an announcement regarding its joint venture Aleor Dermaceuticals. It stated that the latter had received the USFDA’s[1] approval for a generic antifungal cream. This generic version contains Nystatin and Triamcinolone Acetonide cream. It is used for the treatment of cutaneous candidiasis.

In a BSE[2] filing, the pharma firm claimed that Aleor’s ANDA[3] application for this product was approved by the USFDA. This product comprises Nystatin and Triamcinolone cream USP[4], 1,00,000 units/gram and 1 mg/gram. It is a generic version of Taro Pharmaceuticals Inc’s Nystatin and Triamcinolone Acetonide Cream USP of the same strength.

Per IQVIA[5], the estimated market size of this product is around USD[6] 19 million for 12 months ending December 2020.

Alembic Pharma has over 139 ANDA approvals, of which 123 are final approvals and 16 are tentative approvals from the USFDA.


  • 1. United States Food and Drug Administration
  • 2. Bombay Stock Exchange
  • 3. Abbreviated New Drug Application
  • 4. United States Pharmacopoeia
  • 5. Formerly known as Quintiles and IMS Health

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