Aspen API. More than just an API.
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01 1Aspen API
02 1ChemWerth Inc
03 1LGM Pharma
04 1Omgene Life Sciences Pvt. Ltd
05 1Apicore LLC
06 1Auro Peptides Limited
07 1Aurobindo Pharma Limited
08 1BCN Peptides
09 1Chengdu Shengnuo Biopharm
10 1Chinese Peptide Company
11 1Hybio Pharmaceutical
12 1Jin Dun Medical
13 1Sekisui Medical Co. Ltd
14 1Smaart Pharmaceutticals
15 1Sun Pharmaceutical Industries Limited
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01 4China
02 6India
03 1Japan
04 1Netherlands
05 1Spain
06 2U.S.A
07 2Blank
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01 9Active
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01 17Blank
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01 1230MF10067
02 1230MF10105
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01 1WC-0159
02 16Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-03-07
Pay. Date : 2024-03-05
DMF Number : 13971
Submission : 1999-02-04
Status : Active
Type : II
NDC Package Code : 60870-0476
Start Marketing Date : 2021-08-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-30
Pay. Date : 2021-07-13
DMF Number : 36108
Submission : 2021-07-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25866
Submission : 2012-03-28
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-02-04
Pay. Date : 2015-09-18
DMF Number : 29585
Submission : 2015-07-24
Status : Active
Type : II
NDC Package Code : 35207-0010
Start Marketing Date : 2017-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-04
Pay. Date : 2017-07-27
DMF Number : 30800
Submission : 2016-07-28
Status : Active
Type : II
Registration Number : 230MF10067
Registrant's Address : Hybio Medicine Park, No. 37, Keji C. 2nd St. Shenzhen High-tech Industrial Park, Guangdong, P. R. China 518057
Initial Date of Registration : 2018-05-31
Latest Date of Registration :
NDC Package Code : 14403-0011
Start Marketing Date : 2019-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36902
Submission : 2022-04-28
Status : Active
Type : II
NDC Package Code : 42973-325
Start Marketing Date : 2021-10-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-05-07
Pay. Date : 2020-04-15
DMF Number : 33546
Submission : 2019-12-13
Status : Active
Type : II
Registration Number : 230MF10105
Registrant's Address : 2-1-3 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2018-08-08
Latest Date of Registration :
NDC Package Code : 59651-592
Start Marketing Date : 2021-07-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39994
Submission : 2024-05-29
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40573
Submission : 2024-10-17
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Ganirelix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganirelix, including repackagers and relabelers. The FDA regulates Ganirelix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganirelix 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 Ganirelix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganirelix supplier is an individual or a company that provides Ganirelix active pharmaceutical ingredient (API) or Ganirelix finished formulations upon request. The Ganirelix suppliers may include Ganirelix API manufacturers, exporters, distributors and traders.
click here to find a list of Ganirelix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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