Suppliers / Biotika

Biotika

Slovakia Updated 9 July 2026

Biotika is an API manufacturer based in Slovakia. It holds 2 active US drug master files across a filed portfolio of 2 molecules.

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

What they file, and where

Molecule Regulators Docs
Phenoxymethylpenicillin US FDA 1
Polymyxin B US FDA 1

Also appears on these molecule pages

Polymyxin B API

Questions about Biotika

Does Biotika hold a US DMF or a CEP?
Biotika holds 2 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 Biotika make?
2 molecules are on record against Biotika, including Phenoxymethylpenicillin and Polymyxin B. Each links through to that molecule's full manufacturer list.

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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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