01 1Ipca Laboratories
02 1Viatris
03 2Blank
01 1PLACEBO TABLETS TO MATCH PRIMAQUINE PHOSPHATE TABLETS IN N.Y.
02 1PRIMAQUINE
03 1PRIMAQUINE PHOSPHATE USP
04 1PRIMAQUINE PHOSPHATE, USP
01 1India
02 1U.S.A
03 2Blank
01 2Active
02 2Inactive
01 2Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-07
Pay. Date : 2013-07-30
DMF Number : 25258
Submission : 2011-10-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-16
Pay. Date : 2013-07-22
DMF Number : 27260
Submission : 2013-07-29
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8949
Submission : 1991-02-08
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 86
Submission : 1940-01-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Primaquine Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Primaquine Phosphate, including repackagers and relabelers. The FDA regulates Primaquine Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Primaquine Phosphate 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 Primaquine Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Primaquine Phosphate supplier is an individual or a company that provides Primaquine Phosphate active pharmaceutical ingredient (API) or Primaquine Phosphate finished formulations upon request. The Primaquine Phosphate suppliers may include Primaquine Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Primaquine Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Primaquine Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Primaquine Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Primaquine Phosphate DMFs exist exist since differing nations have different regulations, such as Primaquine Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Primaquine Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Primaquine Phosphate USDMF includes data on Primaquine Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Primaquine Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Primaquine Phosphate suppliers with USDMF on PharmaCompass.
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