Alivira Animal Health Ltd, a wholly owned subsidiary of SeQuent Scientific Limited, has received the US FDA approval for its animal health API (active pharmaceutical ingredients) facility at Visakhapatnam, Andhra Pradesh. With this, Alivira has become the first Indian animal health facility to receive the US FDA approval.
The 225-KL capacity, multi-product facility at Vizag was inspected for the first time by US FDA (Food & Drug Administration) in November 2016 and has now received Establishment Inspection Report (EIR) from US FDA. The receipt of the EIR will enable Alivira’s entry into $ 8 billion US veterinary healthcare market.
“We are pleased with the USFDA approval for our animal health API facility, which is a critical milestone in our journey to build a global animal health business out of India. While we are already working with most of the leading animal health companies’ world over, this approval will enable us expand our reach and consolidate our relationship with these enterprises,” commented Manish Gupta, managing director of Alivira.
Alivira is the largest animal health company from India with annual revenues of $ 120 million. It is also the largest animal health API manufacturer from India. Predominant in anthelmintic, the company has 16 products in the primary therapies across antibiotics, beta agonists, NSAID, antiprotozoal and feed additives. Over the last year, the company has launched five new products and filed for 6 veterinary master files (VMF). The company also has a pipeline of over seven products at different stages at development.
In the formulations space, Alivira has established business presence in India, Turkey, Europe, Latam, Africa, MENA and South East Asia. It has close to 200 dosage forms focused towards production animals produced in GMP compliant facilities in Spain, Turkey, Brazil and India.
