Medshield Re-Certified by FDA DMF 2025–2028 & Leads CNPPA Standard for Pharmaceutical Desiccants

In the tightly regulated world of pharmaceutical packaging, consistency isn’t just a goal—it’s a requirement. That’s why Medshield (Tianhua Tech) is proud to announce its renewed FDA Drug Master File (DMF) certification for 2025–2028, reaffirming our commitment to data integrity, manufacturing transparency, and global compliance.

This re-certification isn’t merely a renewal—it’s validation that our oxygen absorbers, desiccants, and indicators continue to meet the U.S. FDA’s most rigorous standards for material safety, stability, and documentation control. Every batch produced under our GMP Class D facility is traceable, validated, and aligned with the expectations of both regulators and drug manufacturers worldwide.

Beyond regulatory compliance, Medshield has once again been entrusted by the China National Pharmaceutical Packaging Association (CNPPA) to co-author the updated “Guideline on Classification and Application of Pharmaceutical Desiccants.” As one of only a few enterprises designated as a standard-setting unit for oxygen absorbers, desiccants, and moisture/oxygen indicators in China, we recognize this role carries more than technical authority—it carries responsibility.

Our involvement in shaping national guidelines ensures that:

· Specifications reflect real-world stability challenges (e.g., humidity-triggered degradation in lyophilized drugs)

· Testing protocols align with ICH Q1A–Q1E stability principles

· Material compatibility requirements protect sensitive biologics and high-concentration injectables

For pharmaceutical partners, this means more than just sourcing a component. It means partnering with a company that actively defines what “pharmaceutical-grade” truly means—from raw material selection to final packaging validation.

At Medshield, we don’t just follow standards. We help build them—because when patient safety is at stake, there’s no room for ambiguity.