Hikal’s Jigani Plant Passes Brazil’s Toughest Test—Here’s Why It Matters

Hikal Ltd. has achieved a major milestone with its Jigani manufacturing unit in Bengaluru, receiving the coveted Good Manufacturing Practice (GMP) certification from Brazil’s regulatory authority, ANVISA. This certification not only reinforces Hikal’s commitment to global quality standards but also paves the way for expanded business in the Brazilian pharmaceutical market.

 

Key Highlights:

 

Brazilian GMP Certification Secured:

Hikal’s Jigani unit has passed the rigorous GMP audit by ANVISA, Brazil’s National Health Surveillance Agency. This certification, known as Certificado de Boas Práticas de Fabricação (CBPF), is essential for supplying Active Pharmaceutical Ingredients (APIs) to Brazilian customers.

 

Expanded Market Access:

The certification authorizes Hikal to supply four APIs from its Bengaluru site to Brazil, opening new business opportunities and strengthening its presence in Latin America.

 

Reputation for Quality:

Hikal’s facilities have a strong track record, having also received the US FDA’s Establishment Inspection Report (EIR) for both its Bangalore and Panoli units, confirming compliance with stringent global standards.

 

Leadership Speaks:

Manoj Mehrotra, President-Pharma Business at Hikal, highlighted that these achievements validate the company’s commitment to quality and compliance, and will help expand their global reach and partnerships.

 

Industry Impact:

These certifications boost Hikal’s credibility and reliability, attracting new customers and partners worldwide and supporting the company’s growth strategy.

 

With this latest certification, Hikal is well-positioned to serve global pharmaceutical markets and continue its journey of delivering safe, high-quality pharmaceutical solutions.

 

Source: Express Pharma, Indian Pharma Post, Hikal Ltd