Approved Classic Projects of Registration of APIs, Excipients and Packaging Materials
Varieties disclosed in the CDE
1、Octafluoropropane
2、Fluticasone Propionate
3、Pinaverium Bromide
4、Anhydrous Magnesium Citrate
5、Compound ointmentTubes
Registration of APIs
1、Approved Chemical Synthesis APIs
Polyethylene glycol 3350/4000, oseltamivir phosphate, minoxidil, zonisamide, bupivacaine hydrochloride, hexetocaine, diclofenac sodium, aceclofenac, hydroxocobalamin hydrochloride, fluticasone propionate, aminobutril ketoglobate, metformin hydrochloride*, Vitamin A Palmitate(BHA, BHT), Beta Carotene Powder, Vitamin D3 Powder, Dopamine Hydrochloride, Hydroxychloroquine Sulfate, Povidone Iodine, Vigilantin ect.
2、Approved Fermentation APIs
Acarbose, sodium hyaluronate, Ursodeoxycholic acid (enzyme) chlortetracycline hydrochloride, neomycin sulphate, Amphotericin B ,etc.
3、Approved Extraction APIs
Pollen Extract P5/EA10, Lysozyme Hydrochloride, Ursodeoxycholic Acid, Diosmin ,etc.
Registration of Pharmaceutical Excipients & Packaging Materials
1、Approved Pharmaceutical Excipients
Fatty Acid Glycerides, Brazilian Carnauba Wax, (Multi-type) Polyvinyl Ketone, Butyl Hydroxyanisole, Methacrylic Acid-Ethyl Acrylate Copolymer and its Aqueous Dispersions, Microcrystalline Cellulose, Polyethylene Glycol, Soy Phospholipids (for injection), Mannitol-Crosslinked Polyvinyl Ketone-Polyvinyl Acetate-Polyvinyl Ketone Straight Pressure Preblended Excipients, Lanolin, Microcrystalline Cellulose Gelatinous Silicon Dioxide Copolymer Processing Compound*, etc.
2、Approved Pharmaceutical Packaging Materials
Aluminum-plastic eye ointment tubes, (Multi-type) Pharmaceutical Laminating Film, (Multi-type) Plastic Bottles, Child-safety Caps, PE/PP Eye Drops Bottles, BFS Eye Drops Bottles, (Multi-type) Release Paper, Pharmaceutical Aerosol Valves, Aluminum Spray Cans, Pharmaceutical Ceramic Bottles, Cyclic Olefin Polymer (COP) Bottles, Cellular Cryopreservation Bags, Multi-layer Co-extruded Multi-Compartment Bags for Infusion, etc.
Registration of Special Products
1、Approved Enzyme Substance or Vaccine Adjuvant
Hyaluronidase,, Lysozyme, Trypsin, mPEG-SS-5K,etc.
2、Approved Culture Medium DMF or Nuclide Products
Neural stem cell culture medium, Radioactive embolization microspheres for advanced liver cancer, Cell Culture Freezing Medium, 13C urea, 18F radioactive diagnostic reagent, SFM culture medium, etc.
Approved Classic Projects of DMFs Services
Sterile filter, Polypeptide products and their structural derivatives, Various types of APIs and intermediates, Various types of culture medias, Nuclease, Disposable sterile cell culture kit, Cell Culture Freezing Medium, ELPIS Mesenchymal Stem Cells, etc.
Approved Classic Projects of CEP Services
Sodium hyaluronate, Copovidone, Valine, Sucralfate, Gluconolactone, Vitamin B12, Vitamin D3, Ursodiol (Chemical method and enzymatic method), Lincomycin hydrochloride, Fish oil, Levodopa, Levetiracetam, etc.
