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Pharmaceutical Excipient IPEL china CFDA register Cost & time

 Generic Pharmaceutical Excipient  IPEL china CFDA registration Cost:

ITEM

COST

TIME

NOTE

China CFDA Registration consulting & Legal responsibility Agency

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1 Months

 

Technical documents Translation

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0.5-1 Months

 

CFDA Application Dossier Draft, Pre-review, Submit

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3-5 Months

 

NICPBP Excipient Tests & Follow up

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3-6 Months

 

Bioequivalence /Pharmacokinetics Study & CRO Service Cost

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3-6 Months

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CDE Technical Evaluation & Follow up

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6-9 Months

 

CFDA IPEL Approval & Follow up

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3-6 Months

 

Other (Document Notarization etc.)

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0.5-1 Months

 

Total:

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18-24

Months

Not include the BE cost

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