DMF Grade HDPE Bottles

 In industries like pharmaceuticals, healthcare, and nutraceuticals, maintaining product integrity is non-negotiable. One critical factor in this process is the choice of packaging. DMF grade HDPE bottles have become a preferred packaging solution for many companies because of their superior quality, regulatory compliance, and reliability. 

HDPE bottle with child resistant closure

What Is a Drug Master File (DMF)?

A DMF is a confidential submission to the FDA (U.S. Food and Drug Administration) containing detailed information about a material, component, or process used in the manufacturing of drug products. It provides supporting documentation to assist companies and regulatory bodies in evaluating the safety and quality of these components.

What Is a Type III DMF?

Type III DMFs focus specifically on packaging materials used in pharmaceutical products. These packaging components ensure that the drug product remains stable, uncontaminated, and effective throughout its shelf life. This type of DMF applies to a wide variety of packaging items used in pharmaceutical applications, including bottles, caps, seals, and other protective materials.

Examples of Packaging Materials Covered Under Type III DMFs

HDPE (High-Density Polyethylene) Bottles

Used for tablets, capsules, and liquid formulations.

FDA-compliant, non-leaching, moisture-resistant material.

Often paired with desiccant caps for moisture-sensitive products.

HDPE containers with desiccant cap

Closures and Caps

Child-resistant caps for safety.

Tamper-evident seals to ensure integrity and prevent contamination.

Flexible Films and Foils

 

28mm child resistant cap 

DMF Grade HDPE (High-Density Polyethylene) bottles are bottles manufactured according to the stringent standards outlined in these submissions. They are widely used in pharmaceuticals, biotech, and medical packaging to ensure compliance with regulatory norms.

Key Features of DMF Grade HDPE Bottles

1.Manufactured with US DMF-approved raw materials to meet the highest regulatory standards.

2.Produced in a cGMP compliance to ensure product purity and safety.

3.100% quality inspection using advanced, highly calibrated inspection systems.

4.All pharmaceutical plastic packaging complies with updated USP <661>& <671> standards for material safety and performance.

5.High-capacity production guarantees on-time delivery and supply consistency.

6.Packaging is designed with uniform wall thickness, minimal taper, and concavity to allow for smooth, wrinkle-free labeling, ensuring a professional presentation.