01 1ESSENTIAL PHYTOSTEROLINS INC
01 1STERINOL
01 1Canada
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14349
Submission : 1999-08-03
Status : Active
Type : II
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PharmaCompass offers a list of Benzododecinium bromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Benzododecinium bromide manufacturer or Benzododecinium bromide supplier for your needs.
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A STERINOL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of STERINOL, including repackagers and relabelers. The FDA regulates STERINOL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. STERINOL 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 STERINOL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A STERINOL supplier is an individual or a company that provides STERINOL active pharmaceutical ingredient (API) or STERINOL finished formulations upon request. The STERINOL suppliers may include STERINOL API manufacturers, exporters, distributors and traders.
click here to find a list of STERINOL suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A STERINOL DMF (Drug Master File) is a document detailing the whole manufacturing process of STERINOL active pharmaceutical ingredient (API) in detail. Different forms of STERINOL DMFs exist exist since differing nations have different regulations, such as STERINOL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A STERINOL DMF submitted to regulatory agencies in the US is known as a USDMF. STERINOL USDMF includes data on STERINOL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The STERINOL USDMF is kept confidential to protect the manufacturer’s intellectual property.
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