Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Shandong Chenghui Shuangda Pharmaceutical
03 1Omgene Life Sciences Pvt. Ltd
04 1TAPI Technology & API Services
05 1Curia
06 1Guangzhou Topwork Chemical
07 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 3China
02 1Germany
03 1India
04 1Israel
05 1U.S.A
01 2Active
02 5Blank
01 7Blank
01 7Blank
01 7Blank
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
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 : 39854
Submission : 2024-04-16
Status : Active
Type : II
NDC Package Code : 60722-3015
Start Marketing Date : 2022-07-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-06-03
Pay. Date : 2020-05-15
DMF Number : 34802
Submission : 2020-04-24
Status : Active
Type : II
NDC Package Code : 65089-0060
Start Marketing Date : 2021-02-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
A Brexanolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brexanolone, including repackagers and relabelers. The FDA regulates Brexanolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brexanolone 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 Brexanolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brexanolone supplier is an individual or a company that provides Brexanolone active pharmaceutical ingredient (API) or Brexanolone finished formulations upon request. The Brexanolone suppliers may include Brexanolone API manufacturers, exporters, distributors and traders.
click here to find a list of Brexanolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 7 companies offering Brexanolone
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