Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1ChemWerth Inc
03 1Transo-Pharm USA LLC
04 1LGM Pharma
05 1Rochem International Inc
06 1Tofigh Daru
07 1Omgene Life Sciences Pvt. Ltd
08 1ALP Pharm
09 1BCN Peptides
10 1Chinese Peptide Company
11 1CordenPharma
12 1Eagle Chemical
13 1Guangzhou Tosun Pharmaceutical
14 1Hybio Pharmaceutical
15 1Jiangsu Sinopep Allsino Biopharmaceutical
16 1Jin Dun Medical
17 1Piramal Pharma Solutions
18 1Shenzhen JYMed Technology
19 1Smaart Pharmaceutticals
20 1Sun Pharmaceutical Industries Limited
21 1Blank
01 7China
02 1Germany
03 5India
04 1Iran
05 1Spain
06 5U.S.A
07 1Blank
01 10Active
02 11Blank
01 21Blank
01 1224MF10121
02 1306MF10147
03 19Blank
01 1WC-0237
02 20Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-09-24
Pay. Date : 2019-12-12
DMF Number : 34752
Submission : 2020-05-03
Status : Active
Type : II
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.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-09-01
Pay. Date : 2020-07-20
DMF Number : 34884
Submission : 2020-06-08
Status : Active
Type : II
NDC Package Code : 43963-003
Start Marketing Date : 2024-12-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-06
Pay. Date : 2020-05-21
DMF Number : 34552
Submission : 2020-03-19
Status : Active
Type : II
Date of Issue : 2019-09-03
Valid Till : 2022-09-02
Written Confirmation Number : WC-0237
Address of the Firm :
NDC Package Code : 41701-011
Start Marketing Date : 2011-03-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.45g/.45g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18077
Submission : 2005-02-11
Status : Active
Type : II
Registration Number : 224MF10121
Registrant's Address : 310, Rue de Ransbeek, B-1120 Brussels, Belgium
Initial Date of Registration : 2012-07-04
Latest Date of Registration : --
A Cetrorelix Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetrorelix Acetate, including repackagers and relabelers. The FDA regulates Cetrorelix Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetrorelix Acetate 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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