01 1Huzhou Zhanwang Pharmaceutical
02 1India Phosphate
03 1Luoyang Longmen Pharmaceutical
04 1Prachin Chemical
05 1Blank
01 3DIBASIC CALCIUM PHOSPHATE DIHYDRATE
02 1DIBASIC CALCIUM PHOSPHATE DIHYDRATE USP
03 1EMCOMPRESS (DICALCIUM PHOSPHATE DIHYDRATE)
01 2China
02 2India
03 1Blank
01 4Active
02 1Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37690
Submission : 2022-11-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29479
Submission : 2015-05-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40452
Submission : 2024-09-19
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39811
Submission : 2024-04-03
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3064
Submission : 1977-11-04
Status : Inactive
Type : II
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A Dibasic Calcium Phosphate Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dibasic Calcium Phosphate Dihydrate, including repackagers and relabelers. The FDA regulates Dibasic Calcium Phosphate Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dibasic Calcium Phosphate Dihydrate 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 Dibasic Calcium Phosphate Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dibasic Calcium Phosphate Dihydrate supplier is an individual or a company that provides Dibasic Calcium Phosphate Dihydrate active pharmaceutical ingredient (API) or Dibasic Calcium Phosphate Dihydrate finished formulations upon request. The Dibasic Calcium Phosphate Dihydrate suppliers may include Dibasic Calcium Phosphate Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Dibasic Calcium Phosphate Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dibasic Calcium Phosphate Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dibasic Calcium Phosphate Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Dibasic Calcium Phosphate Dihydrate DMFs exist exist since differing nations have different regulations, such as Dibasic Calcium Phosphate Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dibasic Calcium Phosphate Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Dibasic Calcium Phosphate Dihydrate USDMF includes data on Dibasic Calcium Phosphate Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dibasic Calcium Phosphate Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dibasic Calcium Phosphate Dihydrate suppliers with USDMF on PharmaCompass.
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