Suppliers / Pt Kalbe Farma

Pt Kalbe Farma

Indonesia 609 employees Updated 9 July 2026

Pt Kalbe Farma is a finished-dose manufacturer based in Indonesia. It appears in 42 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with DAV (Vietnam), MCAZ (ZW) and HSA (SG). Its GMP standing is certified by BPOM (ID).

0
active US DMFs
0
valid CEPs
0
registered plants
42
filings across 3 regulators

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 34 None
MCAZ (ZW) 6 None
HSA (SG) 2 None
BPOM (ID) None 32

Limited public record

Beyond the filing counts above, the public registers hold no plant, inspection or portfolio detail for this company as at 9 July 2026. We report that as a gap rather than inferring an answer.

Questions about Pt Kalbe Farma

Does Pt Kalbe Farma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Pt Kalbe Farma. It does have 42 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Which regulators recognise Pt Kalbe Farma's GMP?
Current GMP certificates are on record from BPOM (ID). 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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Comparable suppliers

Dankos Farma also in Indonesia Dexa Medica also in Indonesia Ferron Par Pharmaceuticals also in Indonesia Fonko International Pharmaceuticals also in Indonesia Medikon Prima Laboratories also in Indonesia

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