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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Standard Chem. & Pharm. Co., Ltd to the U.S. FDA. Original Data : FDA Website

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01 ALFUZOSIN HYDROCHLORIDE (1)

02 ATENOLOL USP (1)

03 CHLORZOXAZONE USP (1)

04 CROTAMITON USP (1)

05 DEXTROMETHORPHAN HYDROBROMIDE USP (1)

06 DICLOFENAC EPOLAMINE (1)

07 DICLOFENAC POTASSIUM USP (1)

08 DICLOFENAC SODIUM USP (1)

09 DILTIAZEM HYDROCHLORIDE USP (1)

10 DOXAZOSIN MESYLATE (1)

11 ENTACAPONE (1)

12 GRANISETRON (1)

13 GRANISETRON HYDROCHLORIDE USP (1)

14 LAMOTRIGINE USP (1)

15 LANSOPRAZOLE USP (1)

16 LIDOCAINE USP (1)

17 LOVASTATIN (1)

18 MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN TAIWAN, R.O.C. (1)

19 METAXALONE USP (1)

20 METOPROLOL SUCCINATE USP (1)

21 MIRTAZAPINE USP (1)

22 MUPIROCIN (1)

23 NAFTOPIDIL (1)

24 PHENYLEPHRINE HYDROCHLORIDE USP (1)

25 PHENYLTOLOXAMINE CITRATE USP (1)

26 PRAMOXINE HYDROCHLORIDE, USP (1)

27 PRAZOSIN HYDROCHLORIDE (1)

28 RABEPRAZOLE SODIUM (1)

29 RILUZOLE (1)

30 RIZATRIPTAN BENZOATE USP (1)

31 TERAZOSIN HYDROCHLORIDE (1)

32 THEOPHYLLINE SODIUM GLYCINATE (1)

33 TIMOLOL MALEATE (TMM) (1)

34 TIMOLOL MALEATE USP (1)

35 TOLPERISONE HYDROCHLORIDE (1)

36 ZOLMITRIPTAN (1)

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01 STANDARD CHEM AND PHARM CO LTD (7)

02 SYN TECH CHEM AND PHARM CO LTD (1)

03 SYN-TECH CHEM AND PHARM CO LTD (25)

04 SYNGEN BIOTECH CO LTD (3)

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01 China (9)

02 Taiwan (27)

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01 Active (22)

02 Inactive (14)

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01 Complete (10)

02 Blank (26)

URL Supplier Web Content
STANDARD CHEM AND PHA...
Inactive
19786
N/A
2006-12-01
II
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SYN-TECH CHEM AND PHA...
Inactive
21617
N/A
2008-05-12
II
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SYN-TECH CHEM AND PHA...
Active
8736
Complete
2014-03-06
2014-02-25
1990-09-13
II
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SYN-TECH CHEM AND PHA...
Active
26374
N/A
2012-08-29
II
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STANDARD CHEM AND PHA...
Inactive
13854
N/A
1998-10-16
II
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SYN-TECH CHEM AND PHA...
Active
24962
Complete
2015-03-03
2014-04-30
2011-05-05
II
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SYN-TECH CHEM AND PHA...
Active
12656
N/A
1997-09-10
II
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SYN-TECH CHEM AND PHA...
Active
9899
Complete
2013-04-10
2013-03-27
1992-10-05
II
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SYN-TECH CHEM AND PHA...
Inactive
14659
N/A
2000-01-06
II
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STANDARD CHEM AND PHA...
Inactive
20770
N/A
2007-08-06
II
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