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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Polypeptide Group to the U.S. FDA. Original Data : FDA Website

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01 ACYLINE (1)

02 ALPHA-CORTICOTROPIN (1-24) ACETATE (1)

03 ANTOCIN (1)

04 BIVALIRUDIN (TM-001-2G) (1)

05 CALCITONIN (SALMON) (1)

06 CALCITONIN (SALMON), PH.EUR. (1)

07 DESLORELIN ACETATE (1)

08 DESMOPRESSIN (1)

09 DESMOPRESSIN (ACETATE) (CODE SF278) (1)

10 DESMOPRESSIN ACETATE DRUG SUBSTANCE (1)

11 EPTIFIBATIDE (1)

12 EPTIFIBATIDE DRUG SUBSTANCE (1)

13 EXENATIDE DRUG SUBSTANCE (1)

14 EXENATIDE USP (1)

15 EXENDIN-4 ACETATE (EXENATIDE) (1)

16 GLEPAGLUTIDE (1)

17 HIRULOG (BIVALIRUDIN)- ACTIVE PHARMACEUTICAL INGREDIENT (1)

18 HUMAN SECRETIN ACETATE DRUG SUBSTANCE (1)

19 KL4 ACETATE (SINAPULTIDE) (1)

20 LEUPROLIDE (1)

21 LEUPROLIDE ACETATE (1)

22 LINACLOTIDE DRUG SUBSTANCE (2)

23 LIRAGLUTIDE (1)

24 MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HILLEROD, DENMARK (1)

25 MBI 226, A SYNTHETIC PEPTIDE (1)

26 MPS-69 (SYNTHETIC PEPTIDE) (1)

27 OCTREOTIDE ACETATE (1)

28 OCTREOTIDE ACETATE BY GRANULATION (1)

29 OCTREOTIDE ACETATE DRUG SUBSTANCE (1)

30 PORCINE SECRETIN, ACETATE (1)

31 PRAMLINTIDE (ACETATE) ACTIVE PHARMACEUTICAL INGREDIENT (1)

32 PTH (1-34), HUMAN, ACETATE (1)

33 SECRETIN DRUG SUBSTANCE (1)

34 SEMAGLUTIDE (1)

35 SEMAGLUTIDE DRUG SUBSTANCE (1)

36 SYNTHETIC PEPTIDE MPS-178 (1)

37 SYNTHETIC PEPTIDE MPS-93 (1)

38 SYNTHETIC PEPTIDE SYSTEMS MPS-116 (1)

39 SYNTHETIC PEPTIDES MPS-74, MPS-75, MPS-76, MPS-77, AND MPS-78 (1)

40 TERLIPRESSIN ACETATE (2)

41 TERTOMOTIDE DRUG SUBSTANCE (1)

42 THYMOSIN-A-1, DRUG SUBSTANCE (1)

43 THYMOSIN-ALPHA 1 DRUG SUBSTANCE (1)

44 VASOPRESSIN (2)

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01 NEOMPS INC (6)

02 POLYPEPTIDE LABORATORIES AS (2)

03 POLYPEPTIDE LABORATORIES FRANCE (1)

04 POLYPEPTIDE LABORATORIES INC (11)

05 POLYPEPTIDE LABORATORIES SAN DIEGO INC (1)

06 POLYPEPTIDE LABORATORIES SWEDEN AB (16)

07 POLYPEPTIDE LABS INC (1)

08 POLYPEPTIDE SA (9)

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01 Sweden (4)

02 Switzerland (4)

03 U.S.A (39)

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01 Active (32)

02 Inactive (15)

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01 Complete (10)

02 Blank (37)

URL Supplier Web Content
POLYPEPTIDE LABORATOR...
Active
12522
N/A
1997-05-12
II
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POLYPEPTIDE LABORATOR...
Active
21473
N/A
2008-03-28
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POLYPEPTIDE LABORATOR...
Inactive
7574
N/A
1988-07-06
II
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POLYPEPTIDE SA
Active
28912
N/A
2014-12-05
II
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POLYPEPTIDE LABORATOR...
Active
15684
Complete
2016-01-08
2015-12-21
2001-10-19
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POLYPEPTIDE LABORATOR...
Inactive
12775
N/A
1997-12-02
II
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POLYPEPTIDE LABORATOR...
Active
30881
N/A
2016-10-27
II
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POLYPEPTIDE LABORATOR...
Active
8396
N/A
1990-01-26
II
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POLYPEPTIDE SA
Active
16813
N/A
2003-09-03
II
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POLYPEPTIDE LABORATOR...
Active
23676
Complete
2014-09-17
2013-12-18
2010-04-02
II
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