Direktorat Registrasi ObatValid

GEMCITABINE HYDROCHLORIDE

BPOM Number: GKL2143902149A1
Approved: 1 August 2026
Expiry: 31 July 2031
Form: LARUTAN KONSENTRAT UNTUK INFUS

About This Registration

GEMCITABINE HYDROCHLORIDE is a BPOM-registered direktorat registrasi obat in Indonesia, registered under number GKL2143902149A1. Its current registration status is Valid, with the licence valid until 31 July 2031. The product is registered to CKD OTTO PHARMACEUTICALS - INDONESIA. BPOM first approved this registration in July 2026. All registration data is sourced directly from the official BPOM public database and updated daily.

Registration data updated by BPOM

This product's registration details were changed on 5 August 2026. This may reflect a status change, renewal, or correction by BPOM.

Registration Details

Application: newaero
Packaging: DUS, 1 VIAL @ 5.26 ML
Department: Direktorat Registrasi Obat
Data Last Updated: 5 August 2026

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Registered Owners

CKD OTTO PHARMACEUTICALS - INDONESIA
KAB. BEKASI
NPWP: 741325344011000
owner
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Manufacturing Sites

CKD OTTO PHARMACEUTICALS - INDONESIA
KAB. BEKASI
primary
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Ingredients (1)

GEMCITABINE HYDROCHLORIDE

Market Intelligence

Owner Portfolio: CKD OTTO PHARMACEUTICALS - INDONESIA holds 48 BPOM registrations
Manufacturer Scale: CKD OTTO PHARMACEUTICALS - INDONESIA produces 48 registered products
Update Status: Recently updated (7 days ago)

FDA Cross-Reference

via openFDA

Generic Name: GEMCITABINE HYDROCHLORIDE
Product Type: HUMAN PRESCRIPTION DRUG
Route of Administration: INTRAVENOUS

Data sourced from the U.S. FDA drug label database (openFDA). May not exactly match this product variant.

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