01 1MLA Group
02 1Mallinckrodt Pharmaceuticals
03 1Nitika Pharmaceutical Specialities
04 1Blank
01 1CALCIUM STEARATE USP/NF
02 1MAGNESIUM STEARATE
03 1SODIUM STEARATE
04 1STEAR-O-WET C (CALCIUM STEARATE)
01 2India
02 1Ireland
03 1Blank
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2355
Submission : 1974-11-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35102
Submission : 2020-08-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27262
Submission : 2013-06-21
Status : Inactive
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5877
Submission : 1985-05-06
Status : Inactive
Type : II
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Corporate PDF
A Calcium Stearate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Stearate API, including repackagers and relabelers. The FDA regulates Calcium Stearate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Stearate API 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 Calcium Stearate API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Stearate API supplier is an individual or a company that provides Calcium Stearate API active pharmaceutical ingredient (API) or Calcium Stearate API finished formulations upon request. The Calcium Stearate API suppliers may include Calcium Stearate API API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Stearate API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Stearate API DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Stearate API active pharmaceutical ingredient (API) in detail. Different forms of Calcium Stearate API DMFs exist exist since differing nations have different regulations, such as Calcium Stearate API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Stearate API DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Stearate API USDMF includes data on Calcium Stearate API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Stearate API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Stearate API suppliers with USDMF on PharmaCompass.
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