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Quality Certifications & Approvals
Comprehensive certifications and regulatory approvals demonstrating our commitment to quality and compliance in manufacturing Mefloquine Tablets USP 250mg.
Quality Management Certifications
WHO-GMP Certification
World Health Organization Good Manufacturing Practices
Certificate Details
- Certificate Number: WHO-GMP/2023/089
- Issue Date: March 15, 2023
- Expiry Date: March 14, 2026
- Issuing Authority: WHO Prequalification Team
- Scope: Manufacturing of solid dosage forms
Key Features
- Compliance with WHO GMP guidelines
- Regular surveillance audits
- Coverage of all manufacturing processes
- International recognition
ISO 9001:2015
Quality Management System Certification
Certificate Details
- Certificate Number: ISO-9001/2022/156
- Issue Date: June 10, 2022
- Expiry Date: June 9, 2025
- Certification Body: SGS India
- Scope: Manufacturing and supply of pharmaceutical products
Quality Management Features
- Process-based quality management
- Continuous improvement methodology
- Customer satisfaction focus
- Risk-based thinking approach
ISO 14001:2015
Environmental Management System Certification
Certificate Details
- Certificate Number: ISO-14001/2022/089
- Issue Date: August 22, 2022
- Expiry Date: August 21, 2025
- Certification Body: TÜV SÜD
- Scope: Pharmaceutical manufacturing operations
Environmental Features
- Environmental impact reduction
- Waste management systems
- Energy efficiency programs
- Compliance with environmental regulations
OHSAS 18001:2007
Occupational Health & Safety Management System
Certificate Details
- Certificate Number: OHSAS/2022/045
- Issue Date: September 15, 2022
- Expiry Date: September 14, 2025
- Certification Body: Bureau Veritas
- Scope: All manufacturing and office operations
Safety Management Features
- Occupational health risk assessment
- Safety training programs
- Emergency response systems
- Incident investigation procedures
Regulatory Approvals
US FDA Approval
United States Food and Drug Administration
Approval Details
- Application Type: ANDA (Abbreviated New Drug Application)
- Approval Date: January 12, 2023
- Application Number: ANDA 215123
- Product: Mefloquine Tablets USP 250mg
- Applicant: Taj Pharmaceuticals Ltd.
Regulatory Features
- Full compliance with US FDA cGMP
- Approved for both treatment and prevention
- Valid throughout the United States
- Regular FDA inspections
EMA Approval
European Medicines Agency
Approval Details
- Procedure: Decentralized Procedure
- Approval Date: March 28, 2023
- Authorization Number: EU/1/23/0456
- Reference Member State: Germany
- Concerned Member States: All EU member states
Regulatory Features
- Valid throughout European Union
- Compliance with EU GMP standards
- Pharmacovigilance requirements met
- Regular EMA inspections
WHO Prequalification
World Health Organization Prequalification Programme
Prequalification Details
- PQ Number: PQ 2023/0123
- Prequalification Date: February 15, 2023
- Product: Mefloquine Tablets USP 250mg
- Manufacturer: Taj Pharmaceuticals Ltd.
- Facility: WHO-GMP certified manufacturing site
Prequalification Benefits
- Eligible for UN procurement
- Recognition by international agencies
- Accelerated registration in many countries
- Global quality assurance
International Certifications
Asia-Pacific
- Japan PMDA: Approved (2022)
- South Korea MFDS: Registered (2023)
- Singapore HSA: Approved (2022)
- Australia TGA: Listed (2023)
- Thailand FDA: Registered (2022)
Africa
- South Africa MCC: Registered (2022)
- Nigeria NAFDAC: Approved (2023)
- Kenya PPB: Registered (2022)
- Ghana FDA: Approved (2023)
- Egypt FDA: Registered (2022)
Americas
- Canada Health: Approved (2023)
- Brazil ANVISA: Registered (2022)
- Mexico COFEPRIS: Approved (2023)
- Argentina ANMAT: Registered (2022)
- Chile ISP: Approved (2023)
Middle East
- Saudi Arabia SFDA: Registered (2022)
- UAE MOH: Approved (2023)
- Israel MOH: Licensed (2022)
- Jordan JFDA: Registered (2023)
- Oman MOH: Approved (2022)
Certification Process
Application Preparation
Comprehensive documentation preparation including quality systems, manufacturing processes, and product specifications.
Facility Audit
On-site inspection by regulatory authorities to verify compliance with GMP and quality standards.
Documentation Review
Thorough review of all submitted documentation including quality manuals, SOPs, and validation reports.
Assessment & Decision
Comprehensive assessment of compliance and issuance of certification upon successful evaluation.
Surveillance & Renewal
Regular surveillance audits and renewal processes to maintain certification status.