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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pramlintide, including repackagers and relabelers. The FDA regulates Pramlintide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pramlintide 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pramlintide supplier is an individual or a company that provides Pramlintide active pharmaceutical ingredient (API) or Pramlintide finished formulations upon request. The Pramlintide suppliers may include Pramlintide API manufacturers, exporters, distributors and traders.
click here to find a list of Pramlintide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pramlintide DMF (Drug Master File) is a document detailing the whole manufacturing process of Pramlintide active pharmaceutical ingredient (API) in detail. Different forms of Pramlintide DMFs exist exist since differing nations have different regulations, such as Pramlintide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pramlintide DMF submitted to regulatory agencies in the US is known as a USDMF. Pramlintide USDMF includes data on Pramlintide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pramlintide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pramlintide suppliers with USDMF on PharmaCompass.
We have 3 companies offering Pramlintide
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
