DMF Grade HDPE Bottles

What is DMF?

A Drug Master File (DMF) is a submission made to the U.S. Food and Drug Administration (FDA) that provides confidential information about the facilities, processes, or components used in the manufacturing, processing, packaging, and storing of human drugs. While submitting a DMF is not mandatory, it is often used to support various applications such as Investigational New Drug Applications (IND), New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDA) among others.

DMFs are crucial for maintaining confidentiality while allowing manufacturers to share essential information with regulatory authorities. They help ensure that pharmaceutical products meet safety and efficacy standards without disclosing trade secrets.

Type III DMFs for Packaging Materials

In the context of U.S. Drug Master Files (DMFs), raw resins would typically be included in a Type III DMF, which covers packaging materials used for drug products. Raw resins used in the production of packaging materials, such as bottles, caps, and other container-closure systems, would be included in a Type III DMF submission. Examples of raw resins that may be approved for use in drug packaging include polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), and polyethylene terephthalate (PET).

Information Included in Type III DMF for raw resins

• Detailed chemical composition and specifications of the raw resin material
• Manufacturing process used to produce the raw resin
• Quality control tests and acceptance criteria applied to the raw resin
• Stability data demonstrating the suitability of the raw resin for its intended use in drug packaging
• Toxicological data, if applicable, to support the safety of the raw resin in contact with drug products

DMF Grade Pharmaceutical HDPE Bottle Specifications

Item No	Capacity	Height	Diameter of Body	Neck Finish	Weight	US DMF
GT 31	45ml	61.8 mm	37.8 mm	33-400	7.6g	√
GTN 60	60ml	70.71mm	39.88 mm	33-400	10g	√
GT 127	50ml/60ml	68.5 mm	38.6 mm	33-400	9.9g	√
GT 32	75ml	75.5 mm	43.4 mm	33-400	10g	√
GT 35	85ml	82.0 mm	44.4 mm	33-400	10g	√
GT 95	100ml	82.0 mm	47.5 mm	38-400	13.8g	√
GTS 100	100ml	78 mm	47 mm	38-400	25.3g	√
GT 28	120ml	88.5 mm	50.4 mm	38-400	16g	√
GT 23	150ml	93.0 mm	53.6 mm	38-400	18.3g	√
GT 216	175ml	98.5 mm	55.4 mm	38-400	18.4g	√
GT 51	200ml	106.2 mm	58.5 mm	43-400	22g	√
GT 77	250ml	113.8 mm	62.5 mm	43-400	25.4g	√
GTS 250	250ml	103.5mm	66.68 mm	53-400	40g	√
GT 52	300ml	126.5 mm	65.2 mm	43-400	27.9g	√
GT 50	400ml	130.7 mm	72.6 mm	52-400	33.5g	√
GT 50-A	500ml	147.5 mm	75.5 mm	52-400	36.6g	√
GT 226	750ml	171.9 mm	86.1 mm	53-400	47g	√
GT 126	950ml	165.1mm	98.4 mm	53-400	80g	√

The Advantage of Our DMF Grade HDPE Bottle

• Manufactured with US DMF approved raw materials.
• Manufactured in a class 100,000 Clean room with cGMP compliance.
• 100% quality checking with highly cultured inspection systems.
• All our pharmaceutical plastic packaging is in compliant with the updated USP 661 & 671.
• Calibrated SPI 400 neck profile suitable for all international standard closures.
• High-capacity production to ensure on-time delivery of Products.
• Low-Cost Production to help customer be more competitive.
• System Reliability allows us to reduce labor and material costs to save customer’s money.
• Our pharmaceutical plastic packaging quality is maintained to have uniform wall thickness, minimum taper and concavity allowing even, wrinkle free labelling.

For the Reader

LaiyangPackaging ensures quality control and production efficiencies by making significant investments in Latest Technology. Our HDPE Bottles quality is maintained to have uniform wall thickness, minimum taper and concavity allowing even, wrinkle free labeling