Suppliers / Wockhardt Bio

Wockhardt Bio

Switzerland Updated 9 July 2026

Wockhardt Bio is an API manufacturer based in Switzerland. It holds 8 active US drug master files across a filed portfolio of 8 molecules. Its filings concentrate with US FDA and EMA.

8
active US DMFs
0
valid CEPs
0
registered plants
40
filings across 2 regulators

What they file, and where

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 39 None
EMA 1 None

Questions about Wockhardt Bio

Does Wockhardt Bio hold a US DMF or a CEP?
Wockhardt Bio holds 8 active US drug master files. 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.
What does Wockhardt Bio make?
8 molecules are on record against Wockhardt Bio, including Aripiprazole, Fesoterodine, Fosaprepitant and Paliperidone. Each links through to that molecule's full manufacturer list.
Where does Wockhardt Bio file?
Filings are on record with US FDA and EMA, 40 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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Open risk flags

  • 9 active litigation matters are on record.

Sources on this page

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