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
A Glycomul S manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycomul S, including repackagers and relabelers. The FDA regulates Glycomul S manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycomul S 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 Glycomul S manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycomul S supplier is an individual or a company that provides Glycomul S active pharmaceutical ingredient (API) or Glycomul S finished formulations upon request. The Glycomul S suppliers may include Glycomul S API manufacturers, exporters, distributors and traders.
click here to find a list of Glycomul S suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycomul S DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycomul S active pharmaceutical ingredient (API) in detail. Different forms of Glycomul S DMFs exist exist since differing nations have different regulations, such as Glycomul S USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycomul S DMF submitted to regulatory agencies in the US is known as a USDMF. Glycomul S USDMF includes data on Glycomul S's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycomul S USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycomul S suppliers with USDMF on PharmaCompass.
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