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Regulatory Status & Compliance
Comprehensive regulatory status information for Mefloquine Tablets USP 250mg across global markets and compliance with international standards.
Global Regulatory Status
Regulatory Overview
Mefloquine Tablets USP 250mg by Taj Pharmaceuticals Ltd. is approved and registered in over 75 countries worldwide, with comprehensive regulatory compliance and ongoing pharmacovigilance programs.
75+
Countries Registered
50+
Regulatory Approvals
15+
Major Markets
100%
WHO-GMP Compliance
Major Regulatory Approvals
United States - FDA
Food and Drug Administration
Approval Details
- Status: Approved
- Application Type: ANDA (Abbreviated New Drug Application)
- Approval Date: January 12, 2023
- Application Number: ANDA 215123
- Product Code: AN
- Dosage Form: Tablet
- Strength: 250mg
Regulatory Features
- Full compliance with US cGMP requirements
- Approved for both treatment and prevention of malaria
- Valid throughout all 50 states
- Regular FDA surveillance inspections
- Post-marketing requirements fulfilled
European Union - EMA
European Medicines Agency
Approval Details
- Status: Authorized
- Procedure: Decentralized Procedure
- Authorization Date: March 28, 2023
- Authorization Number: EU/1/23/0456
- Reference Member State: Germany
- Concerned States: All 27 EU member states
- Marketing Authorization: Centralized
Regulatory Features
- Valid throughout European Union
- Compliance with EU GMP Annex 1
- Pharmacovigilance system established
- Periodic Safety Update Reports (PSUR) required
- EMA inspections conducted regularly
WHO - Prequalification
World Health Organization Prequalification Programme
Prequalification Details
- Status: Prequalified
- PQ Number: PQ 2023/0123
- Prequalification Date: February 15, 2023
- Product: Mefloquine Tablets USP 250mg
- Manufacturer: Taj Pharmaceuticals Ltd.
- Facility: WHO-GMP certified site
- Therapeutic Area: Antimalarial
Prequalification Benefits
- Eligible for UN agency procurement
- Recognition by major international agencies
- Accelerated registration in many countries
- Global quality assurance recognition
- Preferred supplier status for tenders
Regional Registration Status
Asia-Pacific Region
Japan
Approved
2022
South Korea
Registered
2023
Singapore
Approved
2022
Australia
Listed
2023
Thailand
Registered
2022
Malaysia
Registered
2023
Indonesia
Registered
2022
Philippines
Approved
2023
Vietnam
Registered
2022
India
Approved
2021
Africa Region
South Africa
Registered
2022
Nigeria
Approved
2023
Kenya
Registered
2022
Ghana
Approved
2023
Egypt
Registered
2022
Morocco
Registered
2023
Tanzania
Registered
2022
Uganda
Approved
2023
Zambia
Registered
2022
Americas Region
Canada
Approved
2023
Brazil
Registered
2022
Mexico
Approved
2023
Argentina
Registered
2022
Chile
Approved
2023
Peru
Registered
2022
Colombia
Approved
2023
Venezuela
Registered
2022
Middle East Region
Saudi Arabia
Registered
2022
UAE
Approved
2023
Israel
Licensed
2022
Jordan
Registered
2023
Oman
Approved
2022
Qatar
Registered
2023
Kuwait
Approved
2022
Bahrain
Registered
2023
Compliance Status
Quality Compliance
- WHO-GMP: Compliant
- ISO 9001:2015: Certified
- US cGMP: Compliant
- EU GMP: Compliant
- PIC/S GMP: Compliant
Documentation Compliance
- CTD Format: Compliant
- eCTD Ready: Available
- Stability Data: ICH Compliant
- Validation Protocols: Complete
- Quality Agreements: In Place
Pharmacovigilance Compliance
- Pharmacovigilance System: Operational
- PSUR Reporting: On Schedule
- Adverse Event Reporting: 24/7
- Risk Management: Active
- Signal Detection: Automated
Pending Registrations
In Progress Registrations
Russia
Under Review
Expected Q2 2024
China
Under Review
Expected Q3 2024
Turkey
Documentation Review
Expected Q1 2024
Pakistan
Site Inspection
Expected Q2 2024
Bangladesh
Under Review
Expected Q1 2024