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
19
PharmaCompass offers a list of Glycomul S API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Glycomul S manufacturer or Glycomul S supplier for your needs.
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A Sorbitan monostearate [USAN:BAN] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sorbitan monostearate [USAN:BAN], including repackagers and relabelers. The FDA regulates Sorbitan monostearate [USAN:BAN] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sorbitan monostearate [USAN:BAN] API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Sorbitan monostearate [USAN:BAN] supplier is an individual or a company that provides Sorbitan monostearate [USAN:BAN] active pharmaceutical ingredient (API) or Sorbitan monostearate [USAN:BAN] finished formulations upon request. The Sorbitan monostearate [USAN:BAN] suppliers may include Sorbitan monostearate [USAN:BAN] API manufacturers, exporters, distributors and traders.
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A Sorbitan monostearate [USAN:BAN] DMF (Drug Master File) is a document detailing the whole manufacturing process of Sorbitan monostearate [USAN:BAN] active pharmaceutical ingredient (API) in detail. Different forms of Sorbitan monostearate [USAN:BAN] DMFs exist exist since differing nations have different regulations, such as Sorbitan monostearate [USAN:BAN] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sorbitan monostearate [USAN:BAN] DMF submitted to regulatory agencies in the US is known as a USDMF. Sorbitan monostearate [USAN:BAN] USDMF includes data on Sorbitan monostearate [USAN:BAN]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sorbitan monostearate [USAN:BAN] USDMF is kept confidential to protect the manufacturer’s intellectual property.
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