Alembic Pharmaceuticals said one of its dermatology-focused joint ventures cleared its first United States Food and Drugs Administration (USFDA) inspection at its new formulation manufacturing facility located at Karakhadi, Gujarat, India without any observations.
The inspection was carried out between 15th October, 2018 and 19th October, 2018. Alembic holds 60% of Aleor, with Orbicular Pharmaceutical Technologies holding the rest.
The JV was formed in April 2016 to develop, manufacture and commercialise dermatology products for worldwide markets.
“We are very pleased to see Aleor make tremendous progress since inception and congratulate the entire team at Aleor for successfully clearing its first inspection”, said Pranav Amin, Managing Director of Alembic.
“This is a result of the dedication, commitment and focus of the entire Aleor team to ensure highest quality standards are maintained and we are very excited to build this organisation on a global platform”, said Dr. M S Mohan, Founder and Managing Director of Orbicular.
Aleor has filed six generic applications with the USFDA so far.
Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
It is one of the leaders in branded generics in India and has a team of over 5000 marketing professionals in the country.
