01 1Celanese
02 1Innovative Pharmacy Solutions
03 1Katwijk Chemie
04 1Mallinckrodt Pharmaceuticals
05 1ORGAMOL PHARMA SOLUTIONS SA
06 1Pliva Hrvatska
01 4PEMOLINE
02 1PEMOLINE 18.75 MG COMPOUNDED CAPSULES
03 1PEMOLINE MALLINCKRODT CODE 1500
01 1Croatia
02 1Ireland
03 1Netherlands
04 1Switzerland
05 2U.S.A
01 1Active
02 5Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12238
Submission : 1996-12-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31268
Submission : 2016-12-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11780
Submission : 1995-12-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13865
Submission : 1998-11-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12796
Submission : 1997-12-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13919
Submission : 1998-12-29
Status : Inactive
Type : II
A Pemoline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pemoline, including repackagers and relabelers. The FDA regulates Pemoline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pemoline 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 Pemoline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pemoline supplier is an individual or a company that provides Pemoline active pharmaceutical ingredient (API) or Pemoline finished formulations upon request. The Pemoline suppliers may include Pemoline API manufacturers, exporters, distributors and traders.
click here to find a list of Pemoline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pemoline DMF (Drug Master File) is a document detailing the whole manufacturing process of Pemoline active pharmaceutical ingredient (API) in detail. Different forms of Pemoline DMFs exist exist since differing nations have different regulations, such as Pemoline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pemoline DMF submitted to regulatory agencies in the US is known as a USDMF. Pemoline USDMF includes data on Pemoline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pemoline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pemoline suppliers with USDMF on PharmaCompass.
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