Suppliers / Lianyungang Guike Pharmaceutical

Lianyungang Guike Pharmaceutical

China 2 employees Updated 9 July 2026

Lianyungang Guike Pharmaceutical is an API manufacturer based in China. It holds one active US drug master file and 2 valid CEPs across a filed portfolio of 3 molecules. Its GMP standing is certified by MFDS (Korea).

1
active US DMFs
2
valid CEPs
1
registered plants
0
filings across 0 regulators

Registered plants

Site FDA FEI
Lianyungang, China Not on file

What they file, and where

Molecule Regulators Docs
Atracurium Besylate EDQM, SFDA (Saudi Arabia) 2
Capecitabine US FDA 1
Cisatracurium EDQM 1

Also appears on these molecule pages

Atracurium API Capecitabine API Cisatracurium API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2

Questions about Lianyungang Guike Pharmaceutical

Does Lianyungang Guike Pharmaceutical hold a US DMF or a CEP?
Lianyungang Guike Pharmaceutical holds 1 active US drug master file and 2 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.
Where does Lianyungang Guike Pharmaceutical manufacture?
1 registered site is on record, in China (Lianyungang). Every site is listed on this page with the register it came from.
What does Lianyungang Guike Pharmaceutical make?
3 molecules are on record against Lianyungang Guike Pharmaceutical, including Atracurium Besylate, Capecitabine and Cisatracurium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Lianyungang Guike Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea). 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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Sources on this page

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