Mumbai, August 18, 2023: Hikal, the preferred long-term partner for leading global life sciences companies, announced a positive achievement with the receipt of two prestigious 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 CBPF (Certificado de Boas Práticas de Fabricação) by the renowned Regulatory Authority of Brazil, ANVISA (Agência Nacional de Vigilância Sanitária).
The EIR was issued post the last inspection of the facility conducted from May 8 to May 12, 2023. The U.S. FDA has determined that the inspection classification of the facility is No Action Initiated (NAI). The EIR from US FDA signifies a comprehensive evaluation and approval of Hikal’s operations in compliance with stringent quality requirements. This landmark accomplishment not only underscores Hikal’s commitment to maintaining the highest quality standards but also opens new avenues for supplying Active Pharmaceutical Ingredients (APIs) from its Panoli facility to its global customer base. Simultaneously, the Brazilian GMP Certification holds immense significance as it grants Hikal the authorization to supply four APIs from its Bengaluru site to customers in Brazil.
Speaking about this achievement, Mr. Manoj Mehrotra, President-Pharma Business, Hikal Limited said, “We are pleased to receive the EIR from US FDA for the Panoli facility and Good Manufacturing Practice (GMP) Certification from Brazilian ANVISA for our Bangalore Facility. It is a testament to our firm commitment to our Quality standards. These achievements not only validate our commitment to quality and compliance but also pave the way for us to expand our reach and serve our global customers more effectively. We are proud of this achievement and are committed to provide safe and reliable solutions to our global partners. We remain steadfast in our pursuit of innovation and quality as we continue to serve the needs of our customers and the healthcare industry worldwide.”