01 1Novartis Pharmaceuticals Corporation
02 1Sun Pharmaceutical Industries Limited
01 2PENTETREOTIDE
01 1India
02 1Switzerland
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9906
Submission : 1992-10-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-03
Pay. Date : 2018-11-19
DMF Number : 32895
Submission : 2018-11-06
Status : Active
Type : II
A Pentetreotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentetreotide, including repackagers and relabelers. The FDA regulates Pentetreotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentetreotide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Pentetreotide supplier is an individual or a company that provides Pentetreotide active pharmaceutical ingredient (API) or Pentetreotide finished formulations upon request. The Pentetreotide suppliers may include Pentetreotide API manufacturers, exporters, distributors and traders.
click here to find a list of Pentetreotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentetreotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentetreotide active pharmaceutical ingredient (API) in detail. Different forms of Pentetreotide DMFs exist exist since differing nations have different regulations, such as Pentetreotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentetreotide DMF submitted to regulatory agencies in the US is known as a USDMF. Pentetreotide USDMF includes data on Pentetreotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentetreotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentetreotide suppliers with USDMF on PharmaCompass.
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