Suppliers / North China Pharmaceutical

North China Pharmaceutical

China reconciled across 33 public records · 17 entities Updated 9 July 2026

North China Pharmaceutical is an API manufacturer based in China. It holds 9 active US drug master files and 5 valid CEPs across a filed portfolio of 11 molecules. Its filings concentrate with INHRR (VE), MINSA (CR) and ZAMRA (ZM). Its GMP standing is certified by MFDS (Korea), EMA and US FDA, among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 6 September 2024 as NAI.

9
active US DMFs
5
valid CEPs
13
registered plants 3 with an FDA FEI number
247
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 6 September 2024 NAI US FDA
  • 17 January 2019 VAI US FDA
  • 10 August 2018 VAI US FDA
  • 29 April 2016 VAI US FDA
  • 11 September 2015 VAI US FDA
  • 1 November 2013 VAI US FDA
  • 18 November 2011 VAI US FDA
  • 11 November 2010 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
China, China 3004090057
HEBEI, China Not on file
Chengde, China Not on file
Shijiazhuang City, China Not on file
Shijiazhuang, China Not on file
SHIJIAZHUANG, China Not on file

7 further sites are on record.

What they file, and where

Molecule Regulators Docs
Amoxicillin Trihydrate EDQM 2
Bacitracin US FDA 2
Amoxicillin EDQM 1
Amphotericin B SFDA (Saudi Arabia) 1
Ampicillin Trihydrate EDQM 1
Cyclosporine US FDA 1
Fidaxomicin US FDA 1
Ivermectin EDQM 1
Lincomycin US FDA 1
Tacrolimus US FDA 1
Show all 11 molecules on file
Vancomycin US FDA 1

Also appears on these molecule pages

Ciclosporin API Cyclosporine API Tacrolimus API Vancomycin API

Filings and GMP by regulator

Regulator Filings GMP certificates
INHRR (VE) 151 None
MINSA (CR) 28 None
ZAMRA (ZM) 20 None
EFDA (ET) 17 None
ARCSA (EC) 14 None
NAFDAC (NG) 10 1
MFDS (Korea) None 4
EMA None 2
US FDA None 1
MHRA (UK) None 1
INVIMA (CO) None 1
ANVISA (Brazil) None 1

Questions about North China Pharmaceutical

Does North China Pharmaceutical hold a US DMF or a CEP?
North China Pharmaceutical holds 9 active US drug master files and 5 valid CEPs. 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.
Is North China Pharmaceutical FDA-registered?
3 sites operated by North China Pharmaceutical carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did North China Pharmaceutical's last inspection go?
The most recent inspection on record closed on 6 September 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does North China Pharmaceutical manufacture?
13 registered sites are on record, in China, Colombia and Nigeria (China, Hebei and Chengde among others). Every site is listed on this page with the register it came from.
What does North China Pharmaceutical make?
11 molecules are on record against North China Pharmaceutical, including Amoxicillin Trihydrate, Bacitracin, Amoxicillin and Amphotericin B. Each links through to that molecule's full manufacturer list.
Which regulators recognise North China Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea), EMA, US FDA, MHRA (UK), INVIMA (CO) and 2 more. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

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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Open risk flags

  • The most recent inspection outcome was NAI, on 6 September 2024.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates