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28 Oct 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/10/28/3175225/23089/en/Lifecore-and-PolyPeptide-Announce-Collaboration-Intended-to-Offer-End-to-End-Peptide-Manufacturing-Solution-for-U-S-Market.html

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04 Jun 2020
// CONTRACTPHARMA
https://www.contractpharma.com/contents/view_breaking-news/2020-06-04/polypeptide-group-partners-with-novavax-on-covid-19-vaccine/

http://pmcisochem.fr/sites/default/files/Polypeptide%20Therapeutic%20Solutions%20and%20PMC%20Isochem%20%20press%20release%20March%2012%202018%20NM.pdf
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12522
Submission : 1997-05-12
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21473
Submission : 2008-03-28
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7574
Submission : 1988-07-06
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28912
Submission : 2014-12-05
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2016-01-08
Pay. Date : 2015-12-21
DMF Number : 15684
Submission : 2001-10-19
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12775
Submission : 1997-12-02
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30881
Submission : 2016-10-27
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8396
Submission : 1990-01-26
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16813
Submission : 2003-09-03
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-09-17
Pay. Date : 2013-12-18
DMF Number : 23676
Submission : 2010-04-02
Status : Active
Type : II

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Certificate Numbers : R1-CEP 1997-091 - Rev 03
Status : Valid
Issue Date : 2022-02-07
Type : Chemical
Substance Number : 471

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CEP/COS
Certificate Numbers : R1-CEP 2000-142 - Rev 04
Status : Valid
Issue Date : 2010-02-12
Type : Chemical and TSE
Substance Number : 712

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CEP/COS
Certificate Numbers : R1-CEP 2006-266 - Rev 00
Status : Valid
Issue Date : 2013-11-27
Type : Chemical and TSE
Substance Number : 712

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Certificate Numbers : R1-CEP 2012-037 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2017-07-12
Type : Chemical
Substance Number : 712

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CEP/COS
Certificate Numbers : R1-CEP 2011-247 - Rev 01
Status : Valid
Issue Date : 2018-11-05
Type : Chemical
Substance Number : 1634

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CEP/COS
Certificate Numbers : R1-CEP 2003-045 - Rev 00
Status : Valid
Issue Date : 2009-02-13
Type : Chemical
Substance Number : 1442

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CEP/COS
Certificate Numbers : R1-CEP 2011-321 - Rev 02
Status : Valid
Issue Date : 2023-01-26
Type : Chemical
Substance Number : 1442

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CEP/COS
Certificate Numbers : R0-CEP 2021-279 - Rev 00
Status : Valid
Issue Date : 2022-04-29
Type : Chemical
Substance Number : 2414

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CEP/COS
Certificate Numbers : R1-CEP 2007-232 - Rev 00
Status : Expired
Issue Date : 2014-08-05
Type : Chemical
Substance Number : 949

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CEP/COS
Certificate Numbers : R1-CEP 2010-169 - Rev 03
Status : Valid
Issue Date : 2022-09-27
Type : Chemical
Substance Number : 949

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About the Company : PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmace...

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About the Company : PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmace...

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About the Company : PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmace...

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About the Company : PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmace...

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About the Company : PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmace...

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About the Company : PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmace...

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About the Company : PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmace...

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About the Company : PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmace...

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About the Company : PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmace...

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About the Company : PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmace...

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Details:
PolyPeptide will produce 2 key intermediates used in the production of Matrix-M to enhance the vaccine’s immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 is a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology.
Lead Product(s): NVX-COV2373,COVID-19 Vaccine, Adjuvanted,Matrix-M
Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuvaxovid
Study Phase: Phase IProduct Type: Vaccine
Sponsor: Novavax
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 04, 2020

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Lead Product(s) : NVX-COV2373,COVID-19 Vaccine, Adjuvanted,Matrix-M
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Novavax
Deal Size : Undisclosed
Deal Type : Partnership
PolyPeptide Group Partners with Novavax on COVID-19 Vaccine
Details : PolyPeptide will produce 2 key intermediates used in the production of Matrix-M to enhance the vaccine’s immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 is a stable, prefusion protein made using Novavax’ proprietary...
Product Name : Nuvaxovid
Product Type : Vaccine
Upfront Cash : Undisclosed
June 04, 2020

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ABOUT THIS PAGE
PolyPeptide Laboratories Sweden AB 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 Laboratories Sweden AB
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