Suppliers / Viwit Pharmaceutical

Viwit Pharmaceutical

China 66 employees Updated 9 July 2026

Viwit Pharmaceutical is an API manufacturer based in China. It holds 11 active US drug master files and 5 valid CEPs across a filed portfolio of 12 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 19 July 2024 as NAI.

11
active US DMFs
5
valid CEPs
4
registered plants 3 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 19 July 2024 NAI US FDA

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

Registered plants

Site FDA FEI
Tengzhou, China Not on file
China, China 3008307561
China, China 3006068789
China, China 3009868618

What they file, and where

Molecule Regulators Docs
Gadobutrol EDQM, US FDA 3
Aprepitant EDQM, US FDA 2
Luliconazole SFDA (Saudi Arabia), US FDA 2
Mirabegron EDQM, US FDA 2
Varenicline SFDA (Saudi Arabia), US FDA 2
Efinaconazole US FDA 1
Fosaprepitant US FDA 1
Gadoteric Acid US FDA 1
Lidocaine EDQM 1
Lifitegrast US FDA 1
Show all 12 molecules on file
Perfluorohexyloctane US FDA 1
Vildagliptin US FDA 1

Also appears on these molecule pages

Aprepitant contract manufacturing Atazanavir contract manufacturing Bortezomib contract manufacturing Brinzolamide contract manufacturing Cinacalcet contract manufacturing Dimethyl contract manufacturing Efinaconazole contract manufacturing Fosaprepitant contract manufacturing Gadobutrol API Gadoteric Acid API Lidocaine API Lifitegrast API
Show 6 more molecule pages
Linagliptin contract manufacturing Mirabegron contract manufacturing Rivaroxaban contract manufacturing Sitagliptin contract manufacturing Varenicline contract manufacturing Vildagliptin contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
US FDA None 1

Questions about Viwit Pharmaceutical

Does Viwit Pharmaceutical hold a US DMF or a CEP?
Viwit Pharmaceutical holds 11 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 Viwit Pharmaceutical FDA-registered?
3 sites operated by Viwit 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 Viwit Pharmaceutical's last inspection go?
The most recent inspection on record closed on 19 July 2024 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Viwit Pharmaceutical manufacture?
4 registered sites are on record, in China (Tengzhou and China among others). Every site is listed on this page with the register it came from.
What does Viwit Pharmaceutical make?
12 molecules are on record against Viwit Pharmaceutical, including Gadobutrol, Aprepitant, Luliconazole and Mirabegron. Each links through to that molecule's full manufacturer list.
Which regulators recognise Viwit Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea) and US FDA. 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

  • 2 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 19 July 2024.

Comparable suppliers

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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
EudraGMDP and national regulators
GMP certificates