Suppliers / Roussel

Roussel

Vietnam Updated 9 July 2026

Roussel is an API and finished-dose manufacturer based in Vietnam. It appears in 76 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with DAV (Vietnam), INFARMED (PT) and INHRR (VE).

0
active US DMFs
0
valid CEPs
0
registered plants
76
filings across 3 regulators

What they file, and where

Molecule Regulators Docs
Azithromycin DAV (Vietnam) 2
Colchicine DAV (Vietnam) 2
Betamethasone DAV (Vietnam) 1
Ciprofloxacin DAV (Vietnam) 1
Dexamethasone DAV (Vietnam) 1
Floctafenine DAV (Vietnam) 1
Pyridoxine DAV (Vietnam) 1
Tramadol DAV (Vietnam) 1

Also appears on these molecule pages

Azithromycin API Ciprofloxacin API Colchicine API Dexamethasone API Tramadol API Betamethasone API

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 42 None
INFARMED (PT) 24 None
INHRR (VE) 10 None

Questions about Roussel

Does Roussel hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Roussel. It does have 76 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
What does Roussel make?
8 molecules are on record against Roussel, including Azithromycin, Colchicine, Betamethasone and Ciprofloxacin. Each links through to that molecule's full manufacturer list.
Where does Roussel file?
Filings are on record with DAV (Vietnam), INFARMED (PT) and INHRR (VE), 76 in total.

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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Comparable suppliers

Jubilant Biosys shares 2 molecules Zhejiang Guobang shares 2 molecules Mahima Life Sciences shares 2 molecules CSPC Ouyi Pharmaceutical shares 2 molecules Imexpharm shares 2 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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