Packaging Material DMF & Excipients - Type III & IV
Primary Packaging material is the material which is directly is contact with the Product and the same material holds the product. The main purpose of Primary packaging is to protect the product from any chemical, biological, climatic or any other hazards which will result in product deterioration.
Some examples of Primary Packaging are - `
Glass Ampoule, Glass Vial, Plastic Bottles, Dropper Bottles, Rubber Stopper, etc
Why Packaging Material DMF???
US FDA requires NDA/ANDA/IND must contain details about drug and packaging that are pertinent to the safety, purity and efficacy of the drug. Similarly other regulatory agencies around the world require such information about primary packaging material and excipients used in drugs.
Seeking the importance of Primary Packaging Material in Pharmaceutical packaging, manufacturers should file US DMF type III for their Packaging Material or prepare DMF for their packaging product which can be submitted to their clients when required.
PPC Provides the Following Services in regards to Primary Packaging material & excipients
- DMF Compilation and Preparation as per requirement of Client
- US DMF Type III DMF DMF Submission and Registration for Packaging material. (Example)
- US DMF Type IV DMF DMF Submission and Registration for Excipients. (Example)
- Quality Audit for Primary Packaging materials Manufacturers
- Review and Annual Updates of DMFs
- Technical Testing of Primary Packaging Material & Excipients
Why work with us???
- Over 20 Years of Industry Experience
- Well Qualified Team
- Have Submitted more than 80 US DMFs type III & IV, worked with major manufacturers in India.
- Some of Products on which PPC has worked on …….
Stip Packaging Aluminium Foil, Blister
Packaging Aluminium Foil, Retort Puches, Alu ALu Blister Foil,
Glass Ampoules, Empty Hard Gelatin Capsules,
Plastic Caps & Closures, Unprinted & Printed Laminates
Tubular Vials,Pouches, Collapsible Aluminium
Tubes, Absorbent Cotton, Rubber Closures, Sucrose
Plastic Tubes, laminated tubes, PVC
Films,Aluminium Bags,Induction sealing Wads,HDPE Bottles,
Colours, Microcrystalline Cellulose, Pet
Bottes etc
