01 1Lonza Inc & Lonza America Inc
01 1GLYCOMUL TS KFG
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24010
Submission : 2010-07-27
Status : Active
Type : IV
20
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A Sorbitan stearate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sorbitan stearate, including repackagers and relabelers. The FDA regulates Sorbitan stearate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sorbitan stearate 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 Sorbitan stearate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sorbitan stearate supplier is an individual or a company that provides Sorbitan stearate active pharmaceutical ingredient (API) or Sorbitan stearate finished formulations upon request. The Sorbitan stearate suppliers may include Sorbitan stearate API manufacturers, exporters, distributors and traders.
click here to find a list of Sorbitan stearate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sorbitan stearate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sorbitan stearate active pharmaceutical ingredient (API) in detail. Different forms of Sorbitan stearate DMFs exist exist since differing nations have different regulations, such as Sorbitan stearate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sorbitan stearate DMF submitted to regulatory agencies in the US is known as a USDMF. Sorbitan stearate USDMF includes data on Sorbitan stearate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sorbitan stearate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sorbitan stearate suppliers with USDMF on PharmaCompass.
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