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China Drug Registration

In China, we have successfully declared and accepted more than 200 varieties, which can help you quickly interpret Chinese laws and regulations and minimize the budget and the risk of failure.




1. Legal basis

Article 39 of the Drug Administration Law of the People's Republic of China, Article 29 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, and Measures for the Administration of Drug Registration.


2. Validity of registration certificate

The drug approval number issued by the State Food and Drug Administration, the Imported Drug Registration Certificate or the Medical Product Registration Certificate is valid for 5 years. If the validity period expires and production or import is required, the applicant shall apply for re-registration 6 months before the expiration of the validity period.


3. Applicant qualification

Domestic applicants shall be institutions legally registered in China and able to bear civil liability independently, and overseas applicants shall be overseas legal pharmaceutical manufacturers. The registration of imported drugs by an overseas applicant shall be handled by its office in China or by a domestic agency entrusted by it.


4. Registered drug requirements

The API for importation shall be approved by the country or region where the foreign pharmaceutical manufacturer is located.


5. Registration classification of drugs

5.1. drugs that are not marketed at home and abroad;

5.2. a preparation that changes the route of administration and has not been marketed at home and abroad;

5.3 Drugs that have been listed for sale abroad but have not yet been marketed in China;

5.4 A drug substance and a preparation thereof which change the acidity, base (or metal element) of a salt drug which has been marketed, but do not change its pharmacological action.

5.5 Changing the dosage form of the drug that has been marketed in China, but does not change the formulation of the administration route.

5.6 Raw material medicines or preparations that have national drug standards.


6.other

In the implementation of registration management of APIs in China, it is necessary to conduct relevant technical review. After passing the examination, the drug approval number, the “Import Drug Registration Certificate” or the “Pharmaceutical Product Registration Certificate” will be issued.


7.the service content

Registration of imported and domestic raw materials; re-registration of imported and domestic raw materials; application for supplementation of imported and domestic raw materials.



Part of the cooperation API


NameCASSourceChina filing
pregabalin148553-50-8IndiaA
Lercanidipine hydrochloride132866-11-6IndiaA
dapoxetine-IndiaA
Perindopril tert-Butylamine107133-36-8IndiaA
Vinpocetine42971-09-5SwitzerlandA
Celecoxib169590-42-5IndiaA
Voriconazole137234-62-9IndiaA
Paroxetine hydrochloride78246-49-8IndiaA
Lamotrigine84057-84-1PolandA
Desogestrel54024-22-5EuropeA
Etonogestrel54048-10-1EuropeA
olopatadine hydrochloride140462-76-6SpainA
Duloxetine hydrochloride136434-34-9TaiwanA
Mesalazine89-57-6EuropeA
naltrexone hydrochloride16676-29-2IndiaA
Formoterol Fumarate43229-80-7SpainA
Tamsulosin HCl80223-99-0TaiwanA
Multiple Digestive Enzyme23593-75-1JapanA
Almagate66827-12-1KoreaA
Ramipril;-IndiaA
amisulpride71675-85-9IndiaA
lamivudine134678-17-4IndiaA
Ursodeoxycholic acid128-13-2KoreaA
Digoxin20830-75-5IndiaA
montelukast sodium151767-02-1IndiaA
Benazepril Hydrochloride-TaiwanA
Fluconazole-IndiaA
[13C] Urea-United StatesA
Vitamin B6/pyridoxine hydrochloride-EuropeA
Selenium Sulfide-IndiaA
Insulin25759-28-8EuropeA
Cefazolin Sodium27164-46-1ItalyA
Nystatin1400-61-9EuropeA
Atorvastatin Calcium134523-03-8IndiaA
Cefdinir91832-40-5IndiaA
Albendazole54965-21-8EuropeA
Risperidone106266-06-2IndiaA
Ambroxol hydrochloride-IndiaA
Efavirenz-IndiaA
Pazopanib hydrochloride635702-64-6TaiwanI
Ranolazine95635-55-5IndiaI
cinacalcet hydrochloride364782-34-3IndiaI
Tetrabenazine58-46-8IndiaI
OSELTAMIVIR PHOSPHATE204255-11-8IndiaI
Bivalirudin128270-60-0TaiwanI
Canagliflozin Tablets32384-65-9IndiaI
Paliperidone199739-10-1India/MaltaI
Ticagrelor274693-27-5IndiaI
Temozolomide85622-93-1IndiaI
VALGANCICLOVIR HYDROCHLORIDE175865-59-5IndiaI
Salmeterol Xinafoate Aerosol94749-08-3India/SwitzerlandI
Fondaparinux sodium114870-03-0IndiaI
Letrozole Tablets112809-51-5India/TaiwanI
Dabigatran Etexilate Mesylate872728-81-9IndiaI
imatinib152459-95-5IndiaI
Sildenafil Citrate171599-83-0IndiaI
Posaconazole171228-49-2IndiaI
Tiotropium Bromide136310-93-5ItalyI
Tacrolimus104987-11-3IndiaI
Gefitinib184475-35-2IndiaI
Pramipexole dihydrochloride191217-81-9IndiaI
Esomeprazole magnesium161973-10-0IndiaI
anastrozole120511-73-1IndiaI
Fingolimod Hydrochloride162359-56-0IndiaI
Etoricoxib202409-33-4IndiaI
Bortezomib179324-69-7IndiaI
Sodium picosulfate10040-45-6IndiaI
Travoprost157283-68-6EuropeI
Topiramate97240-79-4IndiaI
Entacapone130929-57-6EuropeI
latanoprost130209-82-4TaiwanI
icatibant acetate138614-30-9JapanI
Colesevelam182815-44-7TaiwanI
Dutasteride164656-23-9ItalyI
sirolimus53123-88-9EuropeI
sugammadex sodium343306-79-6SpainI
Goserlin65807-02-5SwitzerlandI
linezolid165800-03-3India/TaiwanI
Fluticasone Propionate60731-46-6IndiaI
Goserelin acetate145781-92-6SwitzerlandI
Pirfenidone53179-13-8IndiaI
Lopinavir192725-17-0IndiaI
Lopinavir155213-67-5IndiaI
pomalidomide19171-19-8IndiaI
Azacitidine320-67-2IndiaI
Torasemide56211-40-6IndiaI
Dexlansoprazole213476-12-1India/EuropeI
Cefcapene pivoxil105889-45-0KoreaI
Misoprostol59122-46-2TaiwanI
PROSTACYCLIN SODIUM SALT-TaiwanI
Silodosin-IndiaI
Chlorpheniramine maleate113-92-8IndiaI
Clopidogrel (hydrogen)sulfate135046-48-9IndiaI
Triptorelin57773-63-4SwitzerlandI
Ipratropium Bromide22254-24-6India/EuropeI
magnesium dihydroxide1309-42-8IndiaI
propofol2078-54-8SwitzerlandI
DONEPEZIL HYDROCHLORIDE120011-70-3IndiaI
Bisoprolol fumarate104344-23-2India/EuropeI
palonosetron hydrochloride135729-62-3IndiaI
Oxaliplatin63121-00-6India/EuropeI
Sodium Bicarbonate144-55-8IndiaI
Magnesium Trisilicate14987-04-3IndiaI
Aluminum hydroxide21645-51-2IndiaI
Levetiracetam102767-28-2IndiaI
irinotecan hydrochloride100286-90-6India/TaiwanI
Rosuvastatin calcium147098-20-2India/EuropeI
Desloratadine100643-71-8IndiaI
Glucosamine hydrochloride66-84-2SpainI
budesonide51372-29-3EuropeI
Bicalutamide90357-06-5IndiaI
Apixaban-IndiaI
Nebivolol hydrochloride-IndiaI
Tizanidine-IndiaI
Simethicone-IndiaI
Tadalafil-IndiaI
gemcitabine hydrochloride122111-03-9IndiaI
Methoxyphenamine hydrochloride5588-10-3ItalyI
calcium levofolinate80433-71-2EuropeI
zoledronic acid118072-93-8IndiaI
MEMANTINE HYDROCHLORIDE41100-52-1IndiaI
Moxifloxacin hydrochloride186826-86-8IndiaI
Docetaxel114977-28-5TaiwanI
Entecavir142217-69-4IndiaI
Nifuratel-EuropeI
Roxatidine acetate hydrochloride93793-83-0KoreaI
Rivaroxaban366789-02-8IndiaI
Metoprolol Succinate98418-47-4EuropeI
Pantoprazole sodium138786-67-1SwitzerlandI


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