Suppliers / Amphastar Nanjing Pharmaceuticals Inc (Anp) An Amphastar

Amphastar Nanjing Pharmaceuticals Inc (Anp) An Amphastar

China Updated 9 July 2026

The public registers hold a second record for Amphastar Nanjing Pharmaceuticals Inc (Anp) An Amphastar. The fuller profile, with 16 active US DMFs and 0 valid CEPs, is at Amphastar Nanjing. Figures on this page cover only this record.

Amphastar Nanjing Pharmaceuticals Inc (Anp) An Amphastar is an API manufacturer based in China. It holds one active US drug master file.

1
active US DMFs
0
valid CEPs
0
registered plants
0
filings across 0 regulators

What they file, and where

Molecule Regulators Docs
Protamine Sulfate US FDA 1

Also appears on these molecule pages

Protamine API

Questions about Amphastar Nanjing Pharmaceuticals Inc (Anp) An Amphastar

Does Amphastar Nanjing Pharmaceuticals Inc (Anp) An Amphastar hold a US DMF or a CEP?
Amphastar Nanjing Pharmaceuticals Inc (Anp) An Amphastar holds 1 active US drug master file. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
What does Amphastar Nanjing Pharmaceuticals Inc (Anp) An Amphastar make?
1 molecule is on record against Amphastar Nanjing Pharmaceuticals Inc (Anp) An Amphastar, including Protamine Sulfate. Each links through to that molecule's full manufacturer list.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability