Neuland Laboratories- A dedicated 100% API provider.
01 2Neuland Laboratories
02 1Curia
03 1MSN Laboratories
04 1Zydus Lifesciences
01 4VOXELOTOR
02 1VOXELOTOR ADIPIC ACID CO-CRYSTAL
01 4India
02 1U.S.A
01 5Active
01 3Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38048
Submission : 2023-04-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38241
Submission : 2023-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-09
Pay. Date : 2022-04-08
DMF Number : 36909
Submission : 2022-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-15
Pay. Date : 2023-08-08
DMF Number : 38512
Submission : 2023-08-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-12
Pay. Date : 2023-09-01
DMF Number : 38271
Submission : 2023-04-08
Status : Active
Type : II
A Voxelotor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Voxelotor, including repackagers and relabelers. The FDA regulates Voxelotor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Voxelotor 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 Voxelotor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Voxelotor supplier is an individual or a company that provides Voxelotor active pharmaceutical ingredient (API) or Voxelotor finished formulations upon request. The Voxelotor suppliers may include Voxelotor API manufacturers, exporters, distributors and traders.
click here to find a list of Voxelotor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Voxelotor DMF (Drug Master File) is a document detailing the whole manufacturing process of Voxelotor active pharmaceutical ingredient (API) in detail. Different forms of Voxelotor DMFs exist exist since differing nations have different regulations, such as Voxelotor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Voxelotor DMF submitted to regulatory agencies in the US is known as a USDMF. Voxelotor USDMF includes data on Voxelotor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Voxelotor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Voxelotor suppliers with USDMF on PharmaCompass.
We have 4 companies offering Voxelotor
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