01 1Hybio Pharmaceutical
02 1MSN Laboratories
03 1Viatris
01 2ABALOPARATIDE
02 1ABALOPARATIDE, NON-STERILE BULK DRUG SUBSTANCE
01 1China
02 1India
03 1U.S.A
01 3Active
01 2Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-08
Pay. Date : 2023-12-08
DMF Number : 39223
Submission : 2023-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-16
Pay. Date : 2022-05-06
DMF Number : 34697
Submission : 2020-05-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36475
Submission : 2021-12-03
Status : Active
Type : II
A Abaloparatide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abaloparatide, including repackagers and relabelers. The FDA regulates Abaloparatide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abaloparatide 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 Abaloparatide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abaloparatide supplier is an individual or a company that provides Abaloparatide active pharmaceutical ingredient (API) or Abaloparatide finished formulations upon request. The Abaloparatide suppliers may include Abaloparatide API manufacturers, exporters, distributors and traders.
click here to find a list of Abaloparatide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Abaloparatide DMF (Drug Master File) is a document detailing the whole manufacturing process of Abaloparatide active pharmaceutical ingredient (API) in detail. Different forms of Abaloparatide DMFs exist exist since differing nations have different regulations, such as Abaloparatide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Abaloparatide DMF submitted to regulatory agencies in the US is known as a USDMF. Abaloparatide USDMF includes data on Abaloparatide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Abaloparatide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Abaloparatide suppliers with USDMF on PharmaCompass.
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