01 1Nordmark Arzneimittel GmbH & Co. KG
02 1Blank
01 1PANCRELIPASE
02 1VIOKASE
01 1Germany
02 1Blank
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7090
Submission : 1987-07-28
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9883
Submission : 1992-09-25
Status : Inactive
Type : II
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A Pancrelipase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pancrelipase, including repackagers and relabelers. The FDA regulates Pancrelipase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pancrelipase 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 Pancrelipase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pancrelipase supplier is an individual or a company that provides Pancrelipase active pharmaceutical ingredient (API) or Pancrelipase finished formulations upon request. The Pancrelipase suppliers may include Pancrelipase API manufacturers, exporters, distributors and traders.
click here to find a list of Pancrelipase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pancrelipase DMF (Drug Master File) is a document detailing the whole manufacturing process of Pancrelipase active pharmaceutical ingredient (API) in detail. Different forms of Pancrelipase DMFs exist exist since differing nations have different regulations, such as Pancrelipase USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pancrelipase DMF submitted to regulatory agencies in the US is known as a USDMF. Pancrelipase USDMF includes data on Pancrelipase's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pancrelipase USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pancrelipase suppliers with USDMF on PharmaCompass.
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