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 3Aspen 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 1Auro Peptides Limited
15 1Aurobindo Pharma Limited
16 2BCN Peptides
17 1Chemi SpA
18 1Chinese Peptide Company
19 1Darmerica
20 1Guangzhou Tosun Pharmaceutical
21 1Hybio Pharmaceutical
22 1Jin Dun Medical
23 2Mallinckrodt Pharmaceuticals
24 1Medisca
25 1Pcca
26 1Peninsula Laboratories
27 36Piramal Pharma Solutions
28 3PolyPeptide Group
29 1ReaLi Tide Biological Technology
30 1Savior Lifetec Corporation
31 1ScinoPharm Taiwan Ltd
32 1Shenzhen JYMed Technology
33 1Smaart Pharmaceutticals
34 1Sun Pharmaceutical Industries Limited
35 11Takeda Pharmaceutical
36 1Teva Pharmaceutical Industries
37 1Viatris
38 1Zhejiang Peptites Biotech Co.,Ltd
39 1Zhejiang Supor Pharmaceuticals Co., LTD
40 4Blank
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01 10China
02 1France
03 9India
04 2Ireland
05 2Israel
06 1Italy
07 11Japan
08 3Netherlands
09 1South Korea
10 2Spain
11 4Switzerland
12 2Taiwan
13 41U.S.A
14 1United Kingdom
15 4Blank
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01 18Active
02 11Inactive
03 65Blank
01 13Valid
02 2Withdrawn by Holder
03 79Blank
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01 1222MF10137
02 1224MF10165
03 1224MF10177
04 1231MF10082
05 1302MF10043
06 89Blank
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01 1WC-0047a3
02 1WC-0159
03 1WC-0237
04 1WC-0443
05 90Blank
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01 120170725-210-J-1
02 120170725-210-J-1(1)
03 120170725-210-J-1(A)
04 120180829-210-J-257
05 120200625-210-J-661
06 120220610-210-J-1313
07 120221026-210-J-1393
08 120221207-210-J-1398
09 120230225-210-J-1451
10 120240605-210-J-1603
11 84Blank
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01 111532-1450
02 111532-1451
03 111532-1452
04 111532-1453
05 111532-1454
06 111532-1455
07 111532-1456
08 111532-1457
09 111532-3338
10 111532-3662
11 111532-3680
12 114799-3005
13 135207-0007
14 138779-2629
15 141524-0006
16 3641701-013
17 151927-0303
18 155463-0002
19 159149-002
20 159651-089
21 160870-0425
22 160870-0471
23 160870-0472
24 171052-620
25 173569-076
26 185151-0001
27 33Blank
01 94Blank
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 : 60870-0471
Start Marketing Date : 2014-06-11
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
Vtides Life Sciences: Innovating peptide design and synthesis for advanced, targeted therapies across key disease areas.
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 |
NDC Package Code : 60870-0472
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 : 11532-1456
Start Marketing Date : 2011-08-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (11.25mg/1.5mL)
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 Lupron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lupron, including repackagers and relabelers. The FDA regulates Lupron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lupron 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 Lupron supplier is an individual or a company that provides Lupron active pharmaceutical ingredient (API) or Lupron finished formulations upon request. The Lupron suppliers may include Lupron API manufacturers, exporters, distributors and traders.
click here to find a list of Lupron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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