Suppliers / Shenzhen Haibin Pharmaceutical

Shenzhen Haibin Pharmaceutical

China Updated 9 July 2026

Shenzhen Haibin Pharmaceutical is an API manufacturer based in China. It holds 6 active US drug master files and 2 valid CEPs across a filed portfolio of 4 molecules. Its filings concentrate with NCELS (KZ), ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by MFDS (Korea) and EMA.

6
active US DMFs
2
valid CEPs
3
registered plants 1 with an FDA FEI number
7
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Shenzhen City, China Not on file
Shenzhen, China Not on file
China, China 3041598181

What they file, and where

Molecule Regulators Docs
Meropenem US FDA 4
Meropenem Trihydrate EDQM 2
Efinaconazole US FDA 1
Oseltamivir US FDA 1

Also appears on these molecule pages

Efinaconazole API Meropenem API Oseltamivir API

Filings and GMP by regulator

Regulator Filings GMP certificates
NCELS (KZ) 4 None
ARCSA (EC) 2 None
INVIMA (CO) 1 None
MFDS (Korea) None 2
EMA None 1

Questions about Shenzhen Haibin Pharmaceutical

Does Shenzhen Haibin Pharmaceutical hold a US DMF or a CEP?
Shenzhen Haibin Pharmaceutical holds 6 active US drug master files 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.
Is Shenzhen Haibin Pharmaceutical FDA-registered?
One site operated by Shenzhen Haibin Pharmaceutical carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
Where does Shenzhen Haibin Pharmaceutical manufacture?
3 registered sites are on record, in China (Shenzhen City, Shenzhen and China). Every site is listed on this page with the register it came from.
What does Shenzhen Haibin Pharmaceutical make?
4 molecules are on record against Shenzhen Haibin Pharmaceutical, including Meropenem, Meropenem Trihydrate, Efinaconazole and Oseltamivir. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shenzhen Haibin Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea) and EMA. 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