US FDA issues one observation for Aleor Dermaceuticals’ Karakhadi unit
The regulator issued one observation after the inspection, as per reports
Alembic Pharmaceuticals said the US health regulator has issued one observation after inspection of Karakhadi facility of its joint venture Aleor Dermaceuticals. Aleor Dermaceuticals is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies, it said in a filing to BSE.
The United States Food and Drug Administration (US FDA) carried out the inspection of Aleor Dermaceuticals’ formulation manufacturing facility at Karakhadi in Gujarat from September 15-20, 2019, it added.
The regulator issued one observation after the inspection, Alembic said. It however did not provide any details about the nature of the observation.
Shares of Alembic Pharma were trading at Rs 546.35 per scrip on BSE, up 5.52 per cent from the previous close.