01 4Roquette
01 1LYCASIN BRAND HYDROGENATED GLUCOSE SYRUP(LYCASIN HGS
02 1LYCASIN BRAND OF HYDROGENATED GLUCOSE SYRUP
03 1NEOSORB 70/20 SORBITOL SOLUTION
04 1SORBITOL POWDER PYROGEN FREE
01 4France
01 1Active
02 3Inactive
01 1Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-30
Pay. Date : 2024-09-05
DMF Number : 34930
Submission : 2020-06-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10879
Submission : 1994-04-15
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6611
Submission : 1986-10-02
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5656
Submission : 1984-11-05
Status : Inactive
Type : IV
A Sorbitol API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sorbitol API, including repackagers and relabelers. The FDA regulates Sorbitol API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sorbitol 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 Sorbitol API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sorbitol API supplier is an individual or a company that provides Sorbitol API active pharmaceutical ingredient (API) or Sorbitol API finished formulations upon request. The Sorbitol API suppliers may include Sorbitol API API manufacturers, exporters, distributors and traders.
click here to find a list of Sorbitol API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sorbitol API DMF (Drug Master File) is a document detailing the whole manufacturing process of Sorbitol API active pharmaceutical ingredient (API) in detail. Different forms of Sorbitol API DMFs exist exist since differing nations have different regulations, such as Sorbitol API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sorbitol API DMF submitted to regulatory agencies in the US is known as a USDMF. Sorbitol API USDMF includes data on Sorbitol API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sorbitol API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sorbitol API suppliers with USDMF on PharmaCompass.
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