01 1FMCCorporation - ICG
02 1Neelkanth Finechem
03 1Particle Dynamics International, LLC.
01 1CALCIUM SULFATE BP/EP/NF
02 1CELOCAL(R) CO-PROCESSED CELLULOSE GEL/CALCIUM SULFATE
03 1DESTAB CALCIUM SULFATE 90 A/A
01 1India
02 2U.S.A
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4935
Submission : 1983-06-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34245
Submission : 2019-10-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15232
Submission : 2000-12-21
Status : Inactive
Type : II
A Karstenite manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Karstenite, including repackagers and relabelers. The FDA regulates Karstenite manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Karstenite 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 Karstenite manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Karstenite supplier is an individual or a company that provides Karstenite active pharmaceutical ingredient (API) or Karstenite finished formulations upon request. The Karstenite suppliers may include Karstenite API manufacturers, exporters, distributors and traders.
click here to find a list of Karstenite suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Karstenite DMF (Drug Master File) is a document detailing the whole manufacturing process of Karstenite active pharmaceutical ingredient (API) in detail. Different forms of Karstenite DMFs exist exist since differing nations have different regulations, such as Karstenite USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Karstenite DMF submitted to regulatory agencies in the US is known as a USDMF. Karstenite USDMF includes data on Karstenite's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Karstenite USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Karstenite suppliers with USDMF on PharmaCompass.
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