Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 2Evonik
02 1Boehringer Ingelheim GmbH
03 1Diqi Pharmaceutical
01 1POLY(D,L-LACTIDE)
02 1POLY(D,L-LACTIDE) AND ITS COPOLYMERS
03 1RESOMER® R FOR PHARMACEUTICAL APPLICATIONS
04 1RESOMER® RG FOR PHARMACEUTICAL APPLICATIONS
01 1China
02 3Germany
01 3Active
02 1Inactive
01 4Blank
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19102
Submission : 2005-10-28
Status : Active
Type : IV
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19103
Submission : 2005-10-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12983
Submission : 1998-04-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37673
Submission : 2022-12-08
Status : Active
Type : IV
A L-Lactide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Lactide, including repackagers and relabelers. The FDA regulates L-Lactide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Lactide 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 L-Lactide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Lactide supplier is an individual or a company that provides L-Lactide active pharmaceutical ingredient (API) or L-Lactide finished formulations upon request. The L-Lactide suppliers may include L-Lactide API manufacturers, exporters, distributors and traders.
click here to find a list of L-Lactide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Lactide DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Lactide active pharmaceutical ingredient (API) in detail. Different forms of L-Lactide DMFs exist exist since differing nations have different regulations, such as L-Lactide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Lactide DMF submitted to regulatory agencies in the US is known as a USDMF. L-Lactide USDMF includes data on L-Lactide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Lactide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Lactide suppliers with USDMF on PharmaCompass.
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