01 1MLA Group
02 1Priti Industries
03 2Tomita Pharmaceutical
01 1CALCIUM SILICATE USP
02 1HYDRATED CALCIUM SILICATE USP
03 1N.F. CALCIUM SILICATE (AS FLORITE R)
04 1NF CALCIUM SILICATE (FLORITE R)
01 2India
02 2Japan
01 2Active
02 2Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35100
Submission : 2020-08-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39250
Submission : 2023-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25928
Submission : 2012-03-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28644
Submission : 2014-09-10
Status : Inactive
Type : IV
A Calsil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calsil, including repackagers and relabelers. The FDA regulates Calsil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calsil 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 Calsil supplier is an individual or a company that provides Calsil active pharmaceutical ingredient (API) or Calsil finished formulations upon request. The Calsil suppliers may include Calsil API manufacturers, exporters, distributors and traders.
click here to find a list of Calsil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calsil DMF (Drug Master File) is a document detailing the whole manufacturing process of Calsil active pharmaceutical ingredient (API) in detail. Different forms of Calsil DMFs exist exist since differing nations have different regulations, such as Calsil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calsil DMF submitted to regulatory agencies in the US is known as a USDMF. Calsil USDMF includes data on Calsil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calsil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calsil suppliers with USDMF on PharmaCompass.
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