Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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
35 2Blank
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
01 18Active
02 11Inactive
03 16Blank
01 13Valid
02 2Withdrawn by Holder
03 30Blank
01 1222MF10137
02 1224MF10165
03 1224MF10177
04 1231MF10082
05 1302MF10043
06 40Blank
01 1WC-0047a3
02 1WC-0159
03 1WC-0237
04 1WC-0443
05 41Blank
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 |
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 : 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
A Leuprolide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leuprolide, including repackagers and relabelers. The FDA regulates Leuprolide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leuprolide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Leuprolide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Leuprolide supplier is an individual or a company that provides Leuprolide active pharmaceutical ingredient (API) or Leuprolide finished formulations upon request. The Leuprolide suppliers may include Leuprolide API manufacturers, exporters, distributors and traders.
click here to find a list of Leuprolide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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