Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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01 1Bachem AG
02 1Omgene Life Sciences Pvt. Ltd
03 1Sanofi
04 2Aspen API
05 1HRV Global Life Sciences
06 1TAPI Technology & API Services
07 1ALP Pharm
08 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
09 1Alembic Pharmaceuticals Limited
10 1AmbioPharm
11 1Anygen
12 1Apino Pharma
13 1Auro Peptides Limited
14 1Aurobindo Pharma Limited
15 2BCN Peptides
16 1Chemi SpA
17 1Chinese Peptide Company
18 1Guangzhou Tosun Pharmaceutical
19 1Hybio Pharmaceutical
20 1Jin Dun Medical
21 2Mallinckrodt Pharmaceuticals
22 1Peninsula Laboratories
23 1Piramal Pharma Solutions
24 2PolyPeptide Group
25 1ReaLi Tide Biological Technology
26 1Savior Lifetec Corporation
27 1ScinoPharm Taiwan, Ltd
28 1Shenzhen JYMed Technology
29 1Smaart Pharmaceutticals
30 1Sun Pharmaceutical Industries Limited
31 6Takeda Pharmaceutical
32 1Teva Pharmaceutical Industries
33 1Viatris
34 1Zhejiang Peptites Biotech Co.,Ltd
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01 10China
02 1France
03 7India
04 2Ireland
05 2Israel
06 1Italy
07 6Japan
08 2Netherlands
09 1South Korea
10 2Spain
11 3Switzerland
12 2Taiwan
13 4U.S.A
14 2Blank
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01 18Active
02 11Inactive
03 16Blank
01 13Valid
02 2Withdrawn by Holder
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01 1222MF10137
02 1224MF10165
03 1224MF10177
04 1231MF10082
05 1302MF10043
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01 1WC-0047a3
02 1WC-0159
03 1WC-0237
04 1WC-0443
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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-02
Pay. Date : 2016-04-29
DMF Number : 13822
Submission : 1998-11-06
Status : Active
Type : II
Certificate Number : R1-CEP 2001-454 - Rev 01
Issue Date : 2009-02-18
Type : Chemical
Substance Number : 1442
Status : Valid
Registration Number : 222MF10137
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2010-04-14
Latest Date of Registration :
NDC Package Code : 55463-0002
Start Marketing Date : 2001-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Hiple Co., Ltd.
Registration Date : 2022-12-07
Registration Number : 20221207-210-J-1398
Manufacturer Name : Bachem AG
Manufacturer Address : Hauptstrasse 144, 4416 Bubendorf, Switzerland
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14440
Submission : 1999-10-08
Status : Inactive
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-29
Pay. Date : 2020-11-09
DMF Number : 28808
Submission : 2014-11-06
Status : Active
Type : II
Certificate Number : R1-CEP 2016-199 - Rev 00
Issue Date : 2022-08-26
Type : Chemical
Substance Number : 1442
Status : Valid
Registration Number : 224MF10165
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2012-08-16
Latest Date of Registration :
NDC Package Code : 60870-0425
Start Marketing Date : 1996-04-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15189
Submission : 2000-12-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-028 - Rev 01
Issue Date : 2015-07-15
Type : Chemical
Substance Number : 1442
Status : Withdrawn by Holder
Certificate Number : R0-CEP 2021-472 - Rev 00
Issue Date : 2022-02-28
Type : Chemical
Substance Number : 1442
Status : Valid
NDC Package Code : 60870-0425
Start Marketing Date : 1996-04-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-15
Pay. Date : 2016-11-29
DMF Number : 31170
Submission : 2016-11-30
Status : Active
Type : II
Date of Issue : 2022-09-07
Valid Till : 2025-06-10
Written Confirmation Number : WC-0443
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25128
Submission : 2011-06-30
Status : Active
Type : II
Certificate Number : CEP 2011-274 - Rev 02
Issue Date : 2024-03-04
Type : Chemical
Substance Number : 1442
Status : Valid
Date of Issue : 2019-09-03
Valid Till : 2022-09-02
Written Confirmation Number : WC-0237
Address of the Firm :
NDC Package Code : 41701-013
Start Marketing Date : 2011-03-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (135g/135g)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-06-05
Registration Number : 20240605-210-J-1603
Manufacturer Name : Piramal Pharma Limited
Manufacturer Address : C-43, MIDC, TTC Industrial Area, Turbhe, Off Thane Belapur Road, Navi Mumbai, District Thane - 400 703, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34847
Submission : 2020-04-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33765
Submission : 2019-08-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-24
Pay. Date : 2014-01-09
DMF Number : 27832
Submission : 2014-01-24
Status : Active
Type : II
Certificate Number : CEP 2014-278 - Rev 01
Issue Date : 2024-12-18
Type : Chemical
Substance Number : 1442
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159
Address of the Firm :
NDC Package Code : 62756-346
Start Marketing Date : 2021-01-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-28
Pay. Date : 2021-01-22
DMF Number : 26716
Submission : 2012-12-11
Status : Active
Type : II
Certificate Number : R1-CEP 2017-193 - Rev 00
Issue Date : 2022-12-16
Type : Chemical
Substance Number : 1442
Status : Valid
Registration Number : 302MF10043
Registrant's Address : Poligono industrial Els Vinyets-Els Fogars. Sector II 08777-Sant Quinti de Mediona, Barcelona, Spain
Initial Date of Registration : 2020-04-02
Latest Date of Registration :
NDC Package Code : 35207-0007
Start Marketing Date : 2017-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : LG Chemical Co., Ltd.
Registration Date : 2023-02-25
Registration Number : 20230225-210-J-1451
Manufacturer Name : BCN PEPTIDES, SA
Manufacturer Address : Pol. Ind. Els Vinyets. Els Fogars, II 08777 SANT QUINTI DE MEDIONA (BARCELONA)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32295
Submission : 2017-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25878
Submission : 2011-12-12
Status : Active
Type : II
Registrant Name : Anygen Inc.
Registration Date : 2018-08-29
Registration Number : 20180829-210-J-257
Manufacturer Name : Anygen Inc.
Manufacturer Address : 123 Nanosandan-ro, Nammyeon, Jangseong-gun, Jeollanam-do, Test Production Building 2 (3-story building) in the Jeollanam-do Nanobio Center
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35071
Submission : 2020-09-14
Status : Active
Type : II
Certificate Number : R0-CEP 2020-305 - Rev 00
Issue Date : 2022-03-04
Type : Chemical
Substance Number : 1442
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13150
Submission : 1998-08-21
Status : Active
Type : II
Certificate Number : R1-CEP 2011-321 - Rev 02
Issue Date : 2023-01-26
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 : 2020-01-28
Valid Till : 2022-06-27
Written Confirmation Number : WC-0047a3
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
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 2003-045 - Rev 00
Issue Date : 2009-02-13
Type : Chemical
Substance Number : 1442
Status : Valid
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9365
Submission : 1991-09-30
Status : Active
Type : II
NDC Package Code : 11532-1450
Start Marketing Date : 1990-10-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (3.75mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2022-10-26
Registration Number : 20221026-210-J-1393
Manufacturer Name : Takeda Pharmaceutical Company Limited
Manufacturer Address : Hikari Plant: 4720, Takeda, Mitsui, Hikari, Yamaguchi 743-8502, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10416
Submission : 1993-08-13
Status : Active
Type : II
NDC Package Code : 11532-1450
Start Marketing Date : 1990-10-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (3.75mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2022-10-26
Registration Number : 20221026-210-J-1393
Manufacturer Name : Takeda Pharmaceutical Company Limited
Manufacturer Address : Hikari Plant: 4720, Takeda, Mitsui, Hikari, Yamaguchi 743-8502, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11395
Submission : 1995-03-24
Status : Active
Type : II
NDC Package Code : 11532-1450
Start Marketing Date : 1990-10-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (3.75mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2022-10-26
Registration Number : 20221026-210-J-1393
Manufacturer Name : Takeda Pharmaceutical Company Limited
Manufacturer Address : Hikari Plant: 4720, Takeda, Mitsui, Hikari, Yamaguchi 743-8502, Japan
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-20
Pay. Date : 2013-01-11
DMF Number : 14763
Submission : 2000-03-07
Status : Active
Type : II
Certificate Number : R1-CEP 2008-115 - Rev 04
Issue Date : 2022-03-10
Type : Chemical
Substance Number : 1442
Status : Valid
Registration Number : 224MF10177
Registrant's Address : Via dei Laboratori 54, 20092 Cinisello Balsamo (Milano), ITALY
Initial Date of Registration : 2012-08-17
Latest Date of Registration :
NDC Package Code : 54127-9002
Start Marketing Date : 2000-03-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12052
Submission : 1996-07-18
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-323 - Rev 02
Issue Date : 2012-07-20
Type : Chemical
Substance Number : 1442
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24845
Submission : 2013-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13922
Submission : 1998-12-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29355
Submission : 2015-04-29
Status : Inactive
Type : II
Registrant Name : Sale Pharmaceutical Co., Ltd.
Registration Date : 2020-06-25
Registration Number : 20200625-210-J-661
Manufacturer Name : Chinese Peptide Company
Manufacturer Address : No. 69, 12 Street, Economic & Technological Development Zone, Hangzhou China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4476
Submission : 1982-01-25
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-441 - Rev 03
Issue Date : 2022-07-29
Type : Chemical
Substance Number : 1442
Status : Valid
NDC Package Code : 11532-1450
Start Marketing Date : 1990-10-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (3.75mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2022-10-26
Registration Number : 20221026-210-J-1393
Manufacturer Name : Takeda Pharmaceutical Company Limited
Manufacturer Address : Hikari Plant: 4720, Takeda, Mitsui, Hikari, Yamaguchi 743-8502, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6142
Submission : 1985-12-23
Status : Inactive
Type : II
NDC Package Code : 11532-1450
Start Marketing Date : 1990-10-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (3.75mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2022-10-26
Registration Number : 20221026-210-J-1393
Manufacturer Name : Takeda Pharmaceutical Company Limited
Manufacturer Address : Hikari Plant: 4720, Takeda, Mitsui, Hikari, Yamaguchi 743-8502, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7021
Submission : 1987-06-09
Status : Inactive
Type : II
NDC Package Code : 11532-1450
Start Marketing Date : 1990-10-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (3.75mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2022-10-26
Registration Number : 20221026-210-J-1393
Manufacturer Name : Takeda Pharmaceutical Company Limited
Manufacturer Address : Hikari Plant: 4720, Takeda, Mitsui, Hikari, Yamaguchi 743-8502, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26380
Submission : 2012-09-05
Status : Inactive
Type : II
NDC Package Code : 41524-0006
Start Marketing Date : 2012-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
34
PharmaCompass offers a list of Leuprolide Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Leuprolide Acetate manufacturer or Leuprolide Acetate supplier for your needs.
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A Leuprolide Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leuprolide Acetate, including repackagers and relabelers. The FDA regulates Leuprolide Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leuprolide Acetate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Leuprolide Acetate supplier is an individual or a company that provides Leuprolide Acetate active pharmaceutical ingredient (API) or Leuprolide Acetate finished formulations upon request. The Leuprolide Acetate suppliers may include Leuprolide Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Leuprolide Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 34 companies offering Leuprolide Acetate
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