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 Pvt. Ltd
08 1Shamrock Pharmachemi
09 1ALP Pharm
10 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
11 1Alembic Pharmaceuticals Limited
12 1AmbioPharm
13 1Anygen
14 1Apicore
15 3Auro Peptides Limited
16 1Aurobindo Pharma Limited
17 2BCN Peptides
18 1Bajaj Healthcare
19 1Chemi SpA
20 1Chinese Peptide Company
21 1Darmerica
22 1Guangzhou Tosun Pharmaceutical
23 1Hybio Pharmaceutical
24 1Jin Dun Medical
25 1Macleods Pharmaceuticals Limited
26 2Mallinckrodt Pharmaceuticals
27 1Medisca
28 1Pcca
29 1Peninsula Laboratories
30 36Piramal Pharma Solutions
31 3PolyPeptide Group
32 1ReaLi Tide Biological Technology
33 1Savior Lifetec Corporation
34 1ScinoPharm Taiwan Ltd
35 1Shenzhen JYMed Technology
36 1Smaart Pharmaceutticals
37 1Sun Pharmaceutical Industries Limited
38 11Takeda Pharmaceutical
39 1Teva Pharmaceutical Industries
40 1Viatris
41 1Zhejiang Peptites Biotech Co.,Ltd
42 1Zhejiang Supor Pharmaceuticals Co., LTD
43 4Blank
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01 10China
02 1France
03 14India
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 19Active
02 11Inactive
03 69Blank
01 13Valid
02 2Withdrawn by Holder
03 84Blank
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01 1222MF10137
02 1224MF10165
03 1224MF10177
04 1231MF10082
05 1302MF10043
06 94Blank
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01 1WC-0047
02 1WC-0159nA2
03 3WC-0443
04 1WC-0549
05 93Blank
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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 89Blank
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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 38Blank
01 99Blank
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: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.
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 |
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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.
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