Alembic Pharma launches oncology site for injectable and lyophilized generics
According to Chirayu Amin, CEO of flagship company Alembic Group, the site has manufacturing capacity for 60 million tablets and capsules, and approximately 20 million vials of liquid injectables and lyophilized concentrates.
Alembic said the facility will make generic cancer medicines for markets in the Middle East and North Africa as well as Australia, South Africa and the US.
Publicly-listed Alembic said the facility – which cost Rs 300 crores (approximately $4.65m) to build - has been fitted with production and processing equipment supplied by Bosch, GEA, Alexanderwerk, ICOS and Tofflon.
Regulatory questions
Alembic has six formulation and three active pharmaceutical ingredient (API) facilities in the Gujarat and Sikkim regions of India.
In June last year, the US Food and Drug Administration (FDA) issued the firm’s Halol, Gujarat-based formulation facility – the only Alembic site to make finished formulations for US export – with a Form 483.
At the time, company secretary Ajay Kumar Desai said the four observations “may not have any bearing on the operations / performance of the company.”
In-PharmaTechnologist requested information on how these observations have been addressed, but Alembic did not respond before the time of publication.
