01 1Dupont
02 1Irvine Scientific Sales Company
03 1Lupin Ltd
04 1MERCK & CIE
05 1SALIENT PHARMACEUTICALS INC
01 1CALCIUM-45
02 1HYDRATED CALCIUM ALUMINOSILICATE UNIFORM PARTICLE SIZE NON-SWELLING (HCAS UPSN)
03 1L-5-METHYL TETRAHYDROFOLATE CALCIUM (AMORPHOUS)
04 1L-METHYLFOLATE CALCIUM
05 1PBS 1X DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION WITHOUT CALCIUM AND MAGNESIUM SALTS - LIQUID
01 1India
02 1Switzerland
03 3U.S.A
01 2Active
02 3Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2709
Submission : 1976-07-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28169
Submission : 2014-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25141
Submission : 2011-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20040
Submission : 2006-12-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20928
Submission : 2007-11-21
Status : Inactive
Type : II
A Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium, including repackagers and relabelers. The FDA regulates Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Calcium supplier is an individual or a company that provides Calcium active pharmaceutical ingredient (API) or Calcium finished formulations upon request. The Calcium suppliers may include Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium active pharmaceutical ingredient (API) in detail. Different forms of Calcium DMFs exist exist since differing nations have different regulations, such as Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium USDMF includes data on Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium suppliers with USDMF on PharmaCompass.
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