Hikal gets Brazilian GMP certification and US FDA EIR for Bangalore and Panoli facilities

Hikal announced the receipt of two certifications – the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) confirming the NAI status and the Good Manufacturing Practice (GMP) Certification known as Certificado de Boas Práticas de Fabricação (CBPF) by the Regulatory Authority of Brazil, Agência Nacional de Vigilância Sanitária (ANVISA).

The EIR was issued post the last inspection of the facility conducted from May 8-12, 2023. The US FDA has determined that the inspection classification of the facility is No Action Initiated (NAI). This opens new avenues for supplying Active Pharmaceutical Ingredients (APIs) from its Panoli facility to its global customer base. The Brazilian GMP Certification grants Hikal the authorisation to supply four APIs from its Bengaluru site to customers in Brazil.

Hikal has five manufacturing facilities in India at Maharashtra (Taloja and Mahad), Gujarat (Panoli) and Bengaluru (Jigani) and a Research & Technology centre at Pune.