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 1Vtides Life Sciences
08 1ALP Pharm
09 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
10 1Alembic Pharmaceuticals Limited
11 1AmbioPharm
12 1Anygen
13 1Apicore
14 1Apino Pharma
15 1Auro Peptides Limited
16 1Aurobindo Pharma Limited
17 2BCN Peptides
18 1Chemi SpA
19 1Chinese Peptide Company
20 1Guangzhou Tosun Pharmaceutical
21 1Hybio Pharmaceutical
22 1Jin Dun Medical
23 2Mallinckrodt Pharmaceuticals
24 1Peninsula Laboratories
25 1Piramal Pharma Solutions
26 2PolyPeptide Group
27 1ReaLi Tide Biological Technology
28 1Savior Lifetec Corporation
29 1ScinoPharm Taiwan, Ltd
30 1Shenzhen JYMed Technology
31 1Smaart Pharmaceutticals
32 1Sun Pharmaceutical Industries Limited
33 6Takeda Pharmaceutical
34 1Teva Pharmaceutical Industries
35 1Viatris
36 1Zhejiang Peptites Biotech Co.,Ltd
37 2Blank
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01 10China
02 1France
03 9India
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 18Blank
01 13Valid
02 2Withdrawn by Holder
03 32Blank
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01 1222MF10137
02 1224MF10165
03 1224MF10177
04 1231MF10082
05 1302MF10043
06 42Blank
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01 1WC-0047a3
02 1WC-0159
03 1WC-0237
04 1WC-0443
05 43Blank
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 : 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 : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (3.75mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Takeda Pharmaceutical Company Korea 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 : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (3.75mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Takeda Pharmaceutical Company Korea 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
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 Leuprorelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leuprorelin, including repackagers and relabelers. The FDA regulates Leuprorelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leuprorelin 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 Leuprorelin supplier is an individual or a company that provides Leuprorelin active pharmaceutical ingredient (API) or Leuprorelin finished formulations upon request. The Leuprorelin suppliers may include Leuprorelin API manufacturers, exporters, distributors and traders.
click here to find a list of Leuprorelin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 36 companies offering Leuprorelin
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