The United States Food and Drug Administration (USFDA) has issued a Form 483 with 5 procedural observations to Alembic Pharmaceuticals after conducting a Pre-Approval Inspection (PAI) at the company’s Solid Oral Formulation facility in Gujarat’s Jarod.
Responding to the development, Alembic Pharmaceuticals, in an exchange filing, emphasised its commitment to high-quality standards and compliance. It claimed that none of the observations were related to data integrity and they believed that the observations can be addressed. The company added that it's working on a befitting response that will be submitted to USFDA within the stipulated period.
Aleor Dermaceuticals Ltd. (Aleor), which was amalgamated with Alembic, filed for the ANDA. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD).
Desonide Cream, 0.05 percent, has an estimated market size of $12 million as of September 2022, according to IQVIA.
Shares of Alembic Pharmaceuticals are trading 0.45 percent lower at Rs 580.60.
