01 1Alkermes Plc
02 1EASTMAN KODAK
03 1Novartis Pharmaceuticals Corporation
01 1GLYCOLIDE
02 1MEDISORB
03 1POLY (DL-LACTIDE-CO-GLYCOLIDE)
01 1Ireland
02 1Switzerland
03 1U.S.A
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8481
Submission : 1990-03-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1973
Submission : 1972-07-27
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6895
Submission : 1987-03-26
Status : Active
Type : II
A Polyglactin 910 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polyglactin 910, including repackagers and relabelers. The FDA regulates Polyglactin 910 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polyglactin 910 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 Polyglactin 910 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polyglactin 910 supplier is an individual or a company that provides Polyglactin 910 active pharmaceutical ingredient (API) or Polyglactin 910 finished formulations upon request. The Polyglactin 910 suppliers may include Polyglactin 910 API manufacturers, exporters, distributors and traders.
click here to find a list of Polyglactin 910 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polyglactin 910 DMF (Drug Master File) is a document detailing the whole manufacturing process of Polyglactin 910 active pharmaceutical ingredient (API) in detail. Different forms of Polyglactin 910 DMFs exist exist since differing nations have different regulations, such as Polyglactin 910 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polyglactin 910 DMF submitted to regulatory agencies in the US is known as a USDMF. Polyglactin 910 USDMF includes data on Polyglactin 910's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polyglactin 910 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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