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 1Apicore
13 1Apino Pharma
14 1Auro Peptides Limited
15 1Aurobindo Pharma Limited
16 2BCN Peptides
17 1Chemi SpA
18 1Chinese Peptide Company
19 1Guangzhou Tosun Pharmaceutical
20 1Hybio Pharmaceutical
21 1Jin Dun Medical
22 2Mallinckrodt Pharmaceuticals
23 1Peninsula Laboratories
24 1Piramal Pharma Solutions
25 2PolyPeptide Group
26 1ReaLi Tide Biological Technology
27 1Savior Lifetec Corporation
28 1ScinoPharm Taiwan, Ltd
29 1Shenzhen JYMed Technology
30 1Smaart Pharmaceutticals
31 1Sun Pharmaceutical Industries Limited
32 6Takeda Pharmaceutical
33 1Teva Pharmaceutical Industries
34 1Viatris
35 1Vtides Life Sciences
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
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 : 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 Enantone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enantone, including repackagers and relabelers. The FDA regulates Enantone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enantone 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 Enantone supplier is an individual or a company that provides Enantone active pharmaceutical ingredient (API) or Enantone finished formulations upon request. The Enantone suppliers may include Enantone API manufacturers, exporters, distributors and traders.
click here to find a list of Enantone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 36 companies offering Enantone
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