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Paracetamol Paracetamol

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List of Drug Master Files (DMF) of Acetaminophen Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 IOL Chemicals and Pharmaceuticals (1)

02 Adare Pharma Solutions (1)

03 Sanofi (3)

04 Seqens (1)

05 ANQIU LUAN PHARMACEUTICAL Co (8)

06 Abbott Laboratories (1)

07 Anhui BBCA Likang pharmaceutical (1)

08 Atabay (1)

09 Aurobindo Pharma Limited (1)

10 Avantor Performance Materials, Inc. (1)

11 BASF (1)

12 Bayer AG (1)

13 Beiersdorf AG (1)

14 Chunghwa Chemical Synthesis & Biotech (1)

15 Dinesh Pharmaceuticals (1)

16 Eli Lilly (1)

17 Farmson Pharmaceutical Gujarat Pvt Ltd (3)

18 Granules India Limited (7)

19 HARTINGTON PHARMACEUTICAL, L.S. (3)

20 Hebei Jiheng Pharmaceutical Co Ltd (4)

21 Industrias Monfel (1)

22 Jinzhou Jiutai Pharmaceutical (1)

23 Mallinckrodt Pharmaceuticals (11)

24 Meghmani Group (2)

25 Rhodia Organique SAS (1)

26 Sri Krishna Pharmaceuticals (3)

27 Yamamoto Corporation (1)

28 Zhejiang Kangle Pharmaceutical (3)

29 Zhejiang Ruibang Laboratories (1)

30 Blank (18)

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01 ACETAMINOFEN (1)

02 ACETAMINOPHEN (15)

03 ACETAMINOPHEN (BULK) (1)

04 ACETAMINOPHEN (PARACETAMOL) (1)

05 ACETAMINOPHEN 90% (1)

06 ACETAMINOPHEN CAPSULES (1)

07 ACETAMINOPHEN CONTROLLED-RELEASE BEADS 325 MG. (1)

08 ACETAMINOPHEN D.C. 90 PVP (1)

09 ACETAMINOPHEN D.C. PVP (1)

10 ACETAMINOPHEN DC 90 3 (1)

11 ACETAMINOPHEN DC 90 6 (1)

12 ACETAMINOPHEN DC 90% (1)

13 ACETAMINOPHEN DC 90-3 SD (1)

14 ACETAMINOPHEN DC 90-9 (1)

15 ACETAMINOPHEN DC GRANULAR (1)

16 ACETAMINOPHEN DC-PGS (1)

17 ACETAMINOPHEN DC90 (1)

18 ACETAMINOPHEN DC90 FINE (1)

19 ACETAMINOPHEN DC90-7SD (1)

20 ACETAMINOPHEN GRANULES DC 90% (1)

21 ACETAMINOPHEN GRANULES DC 90% (KRISOPAP 90F) (1)

22 ACETAMINOPHEN USP (12)

23 ACETAMINOPHEN USP (PARACETAMOL USP) (1)

24 ACETAMINOPHEN USP XX (1)

25 ACETAMINOPHEN USP XX PWD & ACETAMINOPHEN W/10% STARCH (1)

26 ACETAMINOPHEN, BULK FORM (1)

27 ACETAMINOPHEN, OTC (1)

28 ACETAMINOPHEN, USP (1)

29 ACETAMINOPHEN,73% GRANULATION (1)

30 APAP MICROCAPS (1)

31 Acetaminophen DC90-10 SD (1)

32 CAPSULES --ACETAMINOPHEN-325MG; CAFFEINE 40MG; & BUTALBITAL 50MG (1)

33 COATED PARACETAMOL POWDER (1)

34 COMPAP 90 (ACETAMINOPHEN USP 90% ANHYDROUS BASIS) (1)

35 COMPAP SDCRSL (1)

36 COMPAP WSE, CODE 2907 (1)

37 COMPAP™ (1)

38 COMPAP™ COURSE L (1)

39 COMPRESSO PAP 90 CPC (1)

40 COMPRESSO PAP 90 CPF (1)

41 COMPRESSO PAP 90 CPL (1)

42 COMPRESSO-90-CP(F) (ACETAMINOPHEN GRANULES 90%) (1)

43 COMPRESSO-90-P (ACETAMINOPHEN GRANULES 90%) (1)

44 Compap™ L (Acetaminophen USP 90% Anhydrous Basis) (1)

45 DIRECTLY COMPRESSIBLE ACETAMINOPHEN 73% (E-Z 180) (1)

46 DIRECTLY COMPRESSIBLE ACETAMINOPHEN DC-90A (1)

47 DIRECTLY COMPRESSIBLE ACETAMINOPHEN DC-90B (1)

48 HYDROCODONE/ACETAMINOPHEN EXTENDED RELEASE TABLETS (1)

49 PANEXCEA(TM) MC200G (1)

50 PARA-ACETAMINOPHEN (1)

51 PARACETAMOL (3)

52 PARACETAMOL (ACETOMINOPHEN) ORAL LA SUSPENSION (1)

53 PARACETAMOL (OR ALTERNATIVELY KNOWN AS ACETAMINOPHEN) (1)

54 PARACETAMOL DC (PVP) 284N (1)

55 PARACETAMOL DC 272N (GELATIN) (1)

56 PARACETAMOL USP (ACETAMINOPHEN USP) (1)

57 RHODAPAP AND RHODAPAP DC PRODUCTS (ACETAMINOPHEN) (1)

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01 China (18)

02 France (5)

03 Germany (3)

04 India (18)

05 Ireland (11)

06 Japan (1)

07 Mexico (1)

08 Spain (3)

09 Taiwan (1)

10 Turkey (1)

11 U.S.A (4)

12 Blank (18)

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01 Active (35)

02 Inactive (49)

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01 Complete (8)

02 Blank (76)

URL Supplier Web Content
33721
Active
2019-06-20
N/A
II
Adare COMPANY BANNER

BioFIT 2023

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
3142
Inactive
1978-02-01
N/A
II
Sanofi Company Banner

BioFIT 2023

Not Confirmed

envelop Contact Supplier
17745
Active
2004-10-05
Complete
2013-04-10
2013-04-04
II
Seqens Company Banner

BioFIT 2023

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
5148
Inactive
1983-11-10
N/A
II
Sanofi Company Banner

BioFIT 2023

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
5048
Inactive
1983-07-22
N/A
II
Sanofi Company Banner

BioFIT 2023

Not Confirmed

envelop Contact Supplier