01 1Abaloparatide
02 1Acyline
03 1Angiotensin II
04 2Arginine Vasopressin
05 3Atosiban
06 2Bivalirudin
07 2Calcitonin
08 1Corticotropin
09 1Degarelix Acetate
10 1Deslorelin
11 1Deslorelin Acetate
12 3Desmopressin Acetate
13 1Difelikefalin Acetate
14 2Eptifibatide
15 3Exenatide
16 1Felypressin
17 1Glepaglutide
18 1Gonadorelin Acetate
19 1Gonadorelin Hydrochloride
20 1Icatibant Acetate
21 3Leuprolide Acetate
22 2Linaclotide
23 1Liraglutide
24 1Macimorelin Acetate
25 1Motixafortide
26 3Octreotide Acetate
27 1Pramlintide
28 3Secretin
29 2Semaglutide
30 1Setmelanotide Acetate
31 1Sinapultide
32 3Somatostatin
33 1Teduglutide
34 1Teriparatide
35 2Teriparatide Acetate
36 3Terlipressin Acetate
37 1Tertomotide
38 1Tetracosactide
39 2Thymalfasin
40 1Triptorelin Pamoate
41 2Zilucoplan Sodium
42 9Blank
01 27Active
02 20Inactive
03 28Blank
01 1Expired
02 9Valid
03 1Withdrawn by Holder
04 64Blank
01 1219MF10020
02 1220MF10039
03 1223MF10041
04 1224MF10122
05 1230MF10022
06 1231MF10082
07 1304MF10128
08 1306MF10047
09 67Blank
01 9WC-0047
02 66Blank
01 120050831-59-A-113-01
02 120050915-59-A-112-02
03 120121121-192-I-106-01
04 120121121-192-I-106-01(1)
05 120121121-192-I-106-01(2)
06 120170725-210-J-1
07 120170725-210-J-1(1)
08 120170725-210-J-1(A)
09 120171030-90-E-135-03
10 120171030-90-E-135-03(1)
11 120171030-90-E-135-03(A)
12 120220105-209-J-1192
13 120220308-209-J-1247
14 120220711-210-J-1331
15 120250708-210-J-1957
16 1Su233-2-ND
17 1Su2617-1-ND(1)-A
18 1Su3127-1-ND
19 1Su434-6-ND
20 1Su434-6-ND(1)
21 55Blank
01 158862-0176
02 158862-0177
03 158862-0179
04 159149-002
05 159149-003
06 159149-004
07 159149-005
08 159149-007
09 159162-0000
10 159162-0001
11 159162-0002
12 163557-0014
13 163557-0021
14 163557-1031
15 163557-2069
16 163557-2070
17 163557-2071
18 163557-2072
19 163586-0002
20 163586-0004
21 163586-0005
22 163586-0006
23 163586-0115
24 163586-0123
25 163586-0124
26 163586-1469
27 163586-3602
28 168067-0397
29 168067-0398
30 168067-0399
31 168067-0400
32 168067-2602
33 43Blank
01 15709
02 15722
03 15855
04 72Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13150
Submission : 1998-08-21
Status : Active
Type : II
Certificate Number : R1-CEP 2003-045 - Rev 00
Issue Date : 2009-02-13
Type : Chemical
Substance Number : 1442
Status : Valid
Registration Number : 231MF10082
Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn
Initial Date of Registration : 2019-04-03
Latest Date of Registration :
Date of Issue : 2025-10-24
Valid Till : 2028-10-23
Written Confirmation Number : WC-0047
Address of the Firm :
NDC Package Code : 59149-002
Start Marketing Date : 2023-04-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Pharmaceutical Co., Ltd.
Registration Date : 2019-04-15
Registration Number : 20170725-210-J-1(A)
Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd.
Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8396
Submission : 1990-01-26
Status : Active
Type : II
Certificate Number : R1-CEP 2006-266 - Rev 00
Issue Date : 2013-11-27
Type : Chemical and TSE
Substance Number : 712
Status : Valid
Registration Number : 306MF10047
Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn
Initial Date of Registration : 2024-03-27
Latest Date of Registration :
NDC Package Code : 63586-0115
Start Marketing Date : 2017-09-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (4g/4g)
Marketing Category : BULK INGREDIENT
Registrant Name : Meditip Co., Ltd.
Registration Date : 2022-03-08
Registration Number : 20220308-209-J-1247
Manufacturer Name : PolyPeptide Laboratories (Sweden) AB
Manufacturer Address : Högerudsgatan 21, Limhamn, 216 13, Sweden
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19646
Submission : 2006-07-31
Status : Active
Type : II
Registration Number : 223MF10041
Registrant's Address : Chausse(')e de Tubize 297, Braine-L'Alleud, 1420, Belgium
Initial Date of Registration : 2011-03-10
Latest Date of Registration :
Date of Issue : 2025-10-24
Valid Till : 2028-10-23
Written Confirmation Number : WC-0047
Address of the Firm :
NDC Package Code : 59149-004
Start Marketing Date : 2023-02-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (250g/250g)
Marketing Category : BULK INGREDIENT
Registrant Name : Meditip Co., Ltd.
Registration Date : 2022-04-28
Registration Number : Su233-2-ND
Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd.
Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14994
Submission : 2000-08-04
Status : Active
Type : II
Certificate Number : R0-CEP 2021-279 - Rev 00
Issue Date : 2022-04-29
Type : Chemical
Substance Number : 2414
Status : Valid
Date of Issue : 2025-10-24
Valid Till : 2028-10-23
Written Confirmation Number : WC-0047
Address of the Firm :
NDC Package Code : 59149-007
Start Marketing Date : 2023-02-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (6g/6g)
Marketing Category : BULK INGREDIENT
Registrant Name : Meditip Co., Ltd.
Registration Date : 2022-07-11
Registration Number : 20220711-210-J-1331
Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd
Manufacturer Address : Plot No. K28, Addtional MIDC, Anandnagar, Ambernath(E), Thane 421 506, Maharashtra State, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16813
Submission : 2003-09-03
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-142 - Rev 04
Issue Date : 2010-02-12
Type : Chemical and TSE
Substance Number : 712
Status : Valid
Registration Number : 224MF10122
Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn
Initial Date of Registration : 2012-07-09
Latest Date of Registration :
NDC Package Code : 63586-0005
Start Marketing Date : 1982-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Ferring Pharmaceutical Co., Ltd.
Registration Date : 2022-01-05
Registration Number : 20220105-209-J-1192
Manufacturer Name : PolyPeptide Laboratories (Sweden) AB
Manufacturer Address : Högerudsgatan 21, Limhamn, 216 13, Sweden
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21473
Submission : 2008-03-28
Status : Active
Type : II
Date of Issue : 2025-10-24
Valid Till : 2028-10-23
Written Confirmation Number : WC-0047
Address of the Firm :
NDC Package Code : 59149-005
Start Marketing Date : 2023-04-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (350g/350g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2011-247 - Rev 01
Issue Date : 2018-11-05
Type : Chemical
Substance Number : 1634
Status : Valid
Registration Number : 220MF10039
Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn
Initial Date of Registration : 2008-02-05
Latest Date of Registration :
NDC Package Code : 63586-0123
Start Marketing Date : 2018-09-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.2g/.2g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-31
Pay. Date : 2013-02-28
DMF Number : 26832
Submission : 2013-02-20
Status : Active
Type : II
Certificate Number : R1-CEP 2011-321 - Rev 02
Issue Date : 2023-01-26
Type : Chemical
Substance Number : 1442
Status : Valid
Registrant Name : BC World Pharmaceutical Co., Ltd.
Registration Date : 2017-12-08
Registration Number : 20170725-210-J-1(1)
Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd.
Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2010-169 - Rev 03
Issue Date : 2022-09-27
Type : Chemical
Substance Number : 949
Status : Valid
Date of Issue : 2025-10-24
Valid Till : 2028-10-23
Written Confirmation Number : WC-0047
Address of the Firm :
Registrant Name : Leaders Bio Co., Ltd.
Registration Date : 2022-09-28
Registration Number : 20171030-90-E-135-03(A)
Manufacturer Name : PolyPeptide Laboratories PVT. LTD.
Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar, Ambernath(E) Thane 421506, Maharashtra State, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-29
Pay. Date : 2015-04-01
DMF Number : 22322
Submission : 2008-12-16
Status : Active
Type : II
Registration Number : 230MF10022
Registrant's Address : 365 Maple Avenue, Torrance, CA 90503, U.S. S. A
Initial Date of Registration : 2018-02-14
Latest Date of Registration :
Registrant Name : Korea BMI Co., Ltd.
Registration Date : 2019-06-24
Registration Number : Su434-6-ND(1)
Manufacturer Name : PolyPeptide Laboratories, Inc.
Manufacturer Address : 365 Maple Avenue Torrance, CA 90503, USA
Polypeptide Group is a supplier offers 57 products (APIs, Excipients or Intermediates).
Find a price of Leuprolide Acetate bulk with DMF, CEP, JDMF, WC offered by Polypeptide Group
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