01 1Mallinckrodt Pharmaceuticals
02 1PolyPeptide Group
03 1Sun Pharmaceutical Industries Limited
01 1PRAMLINTIDE (ACETATE) ACTIVE PHARMACEUTICAL INGREDIENT
02 1PRAMLINTIDE ACETATE
03 1PRAMLINTIDE STD AMYLIN
01 1India
02 1Ireland
03 1Switzerland
01 2Active
02 1Inactive
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12646
Submission : 1997-09-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15096
Submission : 2000-10-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-30
Pay. Date : 2017-03-27
DMF Number : 31548
Submission : 2018-03-29
Status : Active
Type : II
A PRAMLINTIDE ACETATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PRAMLINTIDE ACETATE, including repackagers and relabelers. The FDA regulates PRAMLINTIDE ACETATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PRAMLINTIDE ACETATE 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 PRAMLINTIDE ACETATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PRAMLINTIDE ACETATE supplier is an individual or a company that provides PRAMLINTIDE ACETATE active pharmaceutical ingredient (API) or PRAMLINTIDE ACETATE finished formulations upon request. The PRAMLINTIDE ACETATE suppliers may include PRAMLINTIDE ACETATE API manufacturers, exporters, distributors and traders.
click here to find a list of PRAMLINTIDE ACETATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PRAMLINTIDE ACETATE DMF (Drug Master File) is a document detailing the whole manufacturing process of PRAMLINTIDE ACETATE active pharmaceutical ingredient (API) in detail. Different forms of PRAMLINTIDE ACETATE DMFs exist exist since differing nations have different regulations, such as PRAMLINTIDE ACETATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PRAMLINTIDE ACETATE DMF submitted to regulatory agencies in the US is known as a USDMF. PRAMLINTIDE ACETATE USDMF includes data on PRAMLINTIDE ACETATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PRAMLINTIDE ACETATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PRAMLINTIDE ACETATE suppliers with USDMF on PharmaCompass.
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