Latest news with #BrazilianHealthRegulatoryAgency
Business Standard
17-06-2025
- Business
- Business Standard
Hikal clears ANVISA GMP audit at Bengaluru API unit
Hikal said that it has successfully cleared the Good Manufacturing Practices (GMP) inspection conducted by the Brazilian Health Regulatory Agency (ANVISA) at its API manufacturing unit in Jigani, Bengaluru, Karnataka. The audit, which covered multiple active pharmaceutical ingredients (APIs), was conducted from 14 April to 18 April 2025. The successful completion of the inspection reinforces Hikals compliance with international quality standards and strengthens its position in regulated markets like Brazil. Hikal is engaged in the business of pharmaceuticals, crop protection, and specialty chemicals. The companys consolidated net profit rallied 48.08% to Rs 50.20 crore on 7.44% rise in revenue from operations to Rs 552.40 crore in Q4 FY25 over Q4 FY24. Shares of Hikal rose 0.29% to Rs 377.10 on the BSE.
Business Standard
20-05-2025
- Business
- Business Standard
Wanbury's Patalganga facility receives GMP certification from ANVISA
Wanbury announced that its active pharmaceutical ingredient (API) manufacturing facility at Patalganga has successfully received the Certificate of Good Manufacturing Practices (CBPF) from ANVISA, the Brazilian Health Regulatory Agency. Earlier this month, on 12 May 2025, the company had also received GMP approval from ANVISA for its Tanuku site in Andhra Pradesh. The certification for the Patalganga site follows ANVISAs review of the inspection report of U.S. FDA, along with other documents submitted by the company. Based on the evaluation, ANVISA granted the GMP certification, confirming the facilitys compliance with Brazilian regulatory standards. With this certificate, now both the API manufacturing sites of Wanbury continue to be compliant per ANVISA' s rules & regulations. Wanbury is a pharmaceutical company with a presence in the global API market and domestic branded formulations. The company's consolidated net profit declined 88.12% to Rs 1.22 crore as revenues fell by 8.28% to Rs 133.45 crore in Q3 FY25 as compared with Q3 FY24. The counter declined 1.74% to Rs 299.35 on the BSE.
Business Upturn
12-05-2025
- Business
- Business Upturn
Wanbury's Tanuku facility in Andhra Pradesh completes ANVISA inspection with zero observations
Wanbury Limited announced the successful completion of an inspection by the Brazilian Health Regulatory Agency (ANVISA) at its manufacturing facility in Tanuku, Andhra Pradesh. The inspection was conducted from December 16 to December 20, 2024. According to Wanbury, the inspection concluded with zero observations, indicating full compliance with ANVISA's regulatory standards. The facility was evaluated for adherence to Current Good Manufacturing Practices (cGMP), which are required for pharmaceutical manufacturing. Advertisement Following the inspection, ANVISA granted the Good Manufacturing Practices (GMP) Certificate to the Tanuku facility. The Certificate of Good Manufacturing Practices (Certificado de Boas Práticas de Fabricação – CBPF) has been issued in both English and Portuguese. This certification is necessary for the export of pharmaceutical products to Brazil and demonstrates the facility's compliance with Brazilian regulatory requirements.
