Zifam Pyrex Myanmar Co., Ltd. operates under internationally recognized certifications that reflect our strong commitment to quality, regulatory compliance, and manufacturing excellence.

The company holds a valid:

• Manufacturing License issued by the Ministry of Health, Myanmar
• WHO-GMP Certification for both the Beta-Lactam Block and General Manufacturing Block

These certifications ensure that:

• Manufacturing processes are validated, controlled, and consistently reproducible
• Facilities are designed and maintained to prevent contamination and ensure product integrity
• Products meet stringent international standards for safety, efficacy, and quality
• Operations are maintained in a state of continuous regulatory readiness

• Supports consistent product quality across all batches
• Strengthens confidence among regulatory authorities and partners
• Facilitates alignment with international regulatory expectations
• Enables readiness for regional and global market expansion

Our Quality Control Laboratory is accredited to ISO/IEC 17025:2017 in the field of testing by the ANAB (ANSI National Accreditation Board), Washington DC.

This accreditation confirms that:

• Testing methods are scientifically validated and fit for purpose
• Results are accurate, reliable, and reproducible
• Laboratory systems meet international standards for technical competence

• Ensures high confidence in analytical data and test results
• Supports regulatory submissions and compliance requirements
• Enhances efficiency in quality decision-making and product release
• Strengthens credibility with global partners and regulatory bodies

The combination of WHO-GMP certified manufacturing and an ISO 17025 accredited laboratory reflects a fully integrated quality environment:

• Alignment of manufacturing processes with advanced analytical control
• End-to-end assurance from raw material testing to finished product release
• Capability to meet diverse regulatory and market requirements
• Positioning as a reliable and compliance-driven pharmaceutical manufacturer

These certifications reinforce Zifam Pyrex Myanmar’s dedication to:

• Upholding international standards in manufacturing and testing
• Ensuring consistent product quality and patient safety
• Maintaining regulatory compliance across all operations
• Strengthening long-term partnerships and global presence