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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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    PolyPeptide Group
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    ACYLINE

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    POLYPEPTIDE LABORATOR...
    Active
    12522
    N/A
    1997-05-12
    II
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    ALPHA-CORTICOTROPIN (1-24) ACETATE

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    POLYPEPTIDE LABORATOR...
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    21473
    N/A
    2008-03-28
    II
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    ANTOCIN

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    POLYPEPTIDE LABORATOR...
    Inactive
    7574
    N/A
    1988-07-06
    II
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    BIVALIRUDIN (TM-001-2G)

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    POLYPEPTIDE SA
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    28912
    N/A
    2014-12-05
    II
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    CALCITONIN (SALMON)

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    POLYPEPTIDE LABORATOR...
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    15684
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    2016-01-08
    2015-12-21
    2001-10-19
    II
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    CALCITONIN (SALMON), PH.EUR.

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    POLYPEPTIDE LABORATOR...
    Inactive
    12775
    N/A
    1997-12-02
    II
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    DESLORELIN ACETATE

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    POLYPEPTIDE LABORATOR...
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    30881
    N/A
    2016-10-27
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    DESMOPRESSIN

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    POLYPEPTIDE LABORATOR...
    Active
    8396
    N/A
    1990-01-26
    II
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    DESMOPRESSIN (ACETATE) (CODE SF278)

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    POLYPEPTIDE SA
    Active
    16813
    N/A
    2003-09-03
    II
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    DESMOPRESSIN ACETATE DRUG SUBSTANCE

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    POLYPEPTIDE LABORATOR...
    Active
    23676
    Complete
    2014-09-17
    2013-12-18
    2010-04-02
    II
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    EPTIFIBATIDE

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    POLYPEPTIDE LABORATOR...
    Inactive
    26757
    N/A
    2012-12-21
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    EPTIFIBATIDE DRUG SUBSTANCE

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    POLYPEPTIDE LABORATOR...
    Active
    18565
    N/A
    2005-08-01
    II
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    EXENATIDE DRUG SUBSTANCE

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    POLYPEPTIDE LABORATOR...
    Active
    19646
    N/A
    2006-07-31
    II
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    EXENATIDE USP

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    POLYPEPTIDE LABORATOR...
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    30924
    N/A
    2016-09-28
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    EXENDIN-4 ACETATE (EXENATIDE)

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    POLYPEPTIDE LABORATOR...
    Active
    27714
    Complete
    2015-01-29
    2013-12-13
    2014-01-13
    II
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    GLEPAGLUTIDE

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    POLYPEPTIDE LABORATOR...
    Active
    38184
    N/A
    2023-11-15
    II
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    HIRULOG (BIVALIRUDIN)- ACTIVE PHARM...

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    POLYPEPTIDE SA
    Active
    12797
    N/A
    1997-12-22
    II
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    HUMAN SECRETIN ACETATE DRUG SUBSTAN...

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    POLYPEPTIDE LABORATOR...
    Active
    15402
    N/A
    2001-04-25
    II
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    KL4 ACETATE (SINAPULTIDE)

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    POLYPEPTIDE LABS INC
    Inactive
    16615
    N/A
    2003-05-30
    II
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    LEUPROLIDE

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    POLYPEPTIDE LABORATOR...
    Active
    13150
    N/A
    1998-08-21
    II
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    LEUPROLIDE ACETATE

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    POLYPEPTIDE LABORATOR...
    Active
    26832
    Complete
    2014-03-31
    2013-02-28
    2013-02-20
    II
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    LINACLOTIDE DRUG SUBSTANCE

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    POLYPEPTIDE LABORATOR...
    Active
    25021
    N/A
    2011-06-01
    II
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    LINACLOTIDE DRUG SUBSTANCE

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    POLYPEPTIDE LABORATOR...
    Active
    25025
    N/A
    2011-06-07
    II
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    LIRAGLUTIDE

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    POLYPEPTIDE LABORATOR...
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    35860
    Complete
    2021-09-29
    2021-07-15
    2021-06-24
    II
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    OCTREOTIDE ACETATE

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    POLYPEPTIDE LABORATOR...
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    32863
    Complete
    2019-04-12
    2018-06-13
    2018-06-18
    II
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    OCTREOTIDE ACETATE BY GRANULATION

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    POLYPEPTIDE LABORATOR...
    Inactive
    21704
    N/A
    2008-06-13
    II
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    OCTREOTIDE ACETATE DRUG SUBSTANCE

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    POLYPEPTIDE LABORATOR...
    Active
    14994
    N/A
    2000-08-04
    II
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    PORCINE SECRETIN, ACETATE

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    POLYPEPTIDE LABORATOR...
    Inactive
    15654
    N/A
    2001-10-05
    II
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    PRAMLINTIDE (ACETATE) ACTIVE PHARMA...

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    POLYPEPTIDE SA
    Active
    15096
    N/A
    2000-10-16
    II
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    PTH (1-34), HUMAN, ACETATE

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    POLYPEPTIDE LABORATOR...
    Active
    22322
    Complete
    2015-07-29
    2015-04-01
    2008-12-16
    II
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    SECRETIN DRUG SUBSTANCE

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    POLYPEPTIDE SA
    Active
    24451
    N/A
    2010-12-14
    II
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    SEMAGLUTIDE

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    POLYPEPTIDE SA
    Active
    36101
    Complete
    2021-10-14
    2021-07-19
    2021-07-12
    II
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    SEMAGLUTIDE DRUG SUBSTANCE

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    POLYPEPTIDE SA
    Active
    38177
    Complete
    2023-08-31
    2023-03-27
    2023-08-02
    II
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    TERLIPRESSIN ACETATE

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    POLYPEPTIDE LABORATOR...
    Inactive
    25589
    N/A
    2011-12-21
    II
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    TERLIPRESSIN ACETATE

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    POLYPEPTIDE LABORATOR...
    Active
    34391
    N/A
    2019-12-06
    II
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    TERTOMOTIDE DRUG SUBSTANCE

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    POLYPEPTIDE SA
    Active
    33628
    N/A
    2019-02-25
    II
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    THYMOSIN-A-1, DRUG SUBSTANCE

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    POLYPEPTIDE SA
    Active
    20478
    N/A
    2007-04-27
    II
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    THYMOSIN-ALPHA 1 DRUG SUBSTANCE

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    POLYPEPTIDE LABORATOR...
    Active
    16110
    N/A
    2002-08-22
    II
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    VASOPRESSIN

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    POLYPEPTIDE LABORATOR...
    Inactive
    27577
    N/A
    2013-12-19
    II
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    VASOPRESSIN

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    POLYPEPTIDE LABORATOR...
    Active
    32116
    Complete
    2018-03-02
    2017-10-04
    2017-10-03
    II
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    MANUFACTURING SITE, FACILITIES, PER...

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    POLYPEPTIDE LABORATOR...
    Inactive
    12517
    N/A
    1997-05-23
    II
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    • FDA
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    MBI 226, A SYNTHETIC PEPTIDE

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    NEOMPS INC
    Inactive
    13146
    N/A
    1998-08-18
    II
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    MPS-69 (SYNTHETIC PEPTIDE)

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    NEOMPS INC
    Inactive
    15182
    N/A
    2000-12-07
    II
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    SYNTHETIC PEPTIDE MPS-178

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    NEOMPS INC
    Inactive
    16879
    N/A
    2003-09-23
    II
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    SYNTHETIC PEPTIDE MPS-93

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    NEOMPS INC
    Inactive
    14385
    N/A
    1999-08-31
    II
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    SYNTHETIC PEPTIDE SYSTEMS MPS-116

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    NEOMPS INC
    Inactive
    15118
    N/A
    2000-10-30
    II
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    SYNTHETIC PEPTIDES MPS-74, MPS-75, ...

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    NEOMPS INC
    Inactive
    13907
    N/A
    1998-12-17
    II
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