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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Pt Kimia Farma Persero Tbk to the U.S. FDA. Original Data : FDA Website

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01 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CIATER, INDONESIA. (1)

02 QUINIDINE GLUCONATE (1)

03 QUINIDINE SALTS (1)

04 QUINIDINE SULFATE (1)

05 QUININE HYDROCHLORIDE (1)

06 QUININE SULFATE (1)

07 QUININE SULFATE USP (1)

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01 KIMIA FARMA (1)

02 PT KIMIA FARMA PERSERO TBK (2)

03 PT SINKONA INDONESIA LESTARI (4)

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01 Indonesia (7)

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01 Inactive (7)

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01 Blank (7)

URL Supplier Web Content
PT SINKONA INDONESIA ...
Inactive
12334
N/A
1997-01-24
II
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KIMIA FARMA
Inactive
3066
N/A
1977-10-13
II
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PT SINKONA INDONESIA ...
Inactive
9632
N/A
1992-03-30
II
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PT KIMIA FARMA PERSER...
Inactive
20952
N/A
2007-09-03
II
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PT KIMIA FARMA PERSER...
Inactive
20951
N/A
2007-09-03
II
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PT SINKONA INDONESIA ...
Inactive
19905
N/A
2006-10-24
II
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MANUFACTURING SITE, FACILITIES, PER...

URL Supplier Web Content
PT SINKONA INDONESIA ...
Inactive
9631
N/A
1992-03-30
II
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