Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
01 1Pharmathen SA
02 1Amneal Pharmaceuticals
03 4Avadel Pharmaceuticals
04 2C.T. LAB.FARMACEUTICO Srl
05 1Farmak JSC
06 1Grindeks AS
07 1Hikma Pharmaceuticals
08 4Jazz Pharmaceuticals
09 1Neuraxpharm
10 1RANBAXY LABORATORIES LIMITED
11 2UCB Pharma S.A
01 1Extended Release Granules For Oral Suspension
02 4FOR SUSPENSION, EXTENDED RELEASE;ORAL
03 1INJECTION
04 1ORAL SOLUTION
05 2SOLUTION
06 5SOLUTION;ORAL
07 1Sodium Oxybate 17.5% 10Ml 12 Combined Oral Use
08 1Sodium Oxybate 17.5% 140Ml Oral Use
09 2Solution
10 1Solution for Injection
01 1DISCN
02 1Generic CTD
03 6RX
04 2Schedule G (CDSA I)
05 9Blank
01 2Alcover
02 4LUMRYZ
03 1Natrii oxybutyras
04 3SODIUM OXYBATE
05 2XYREM
06 2XYWAV
07 2Xyrem
08 3Blank
01 2Canada
02 1Greece
03 2Italy
04 1Latvia
05 1Spain
06 1Sweden
07 1Switzerland
08 9USA
09 1Ukraine
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Gamma-Hydroxybutyric Acid Sodium
Brand Name :
Dosage Form : Extended Release Granules For Oral Suspension
Dosage Strength : 500MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
Regulatory Info :
Registration Country : USA
Brand Name : SODIUM OXYBATE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 500MG/ML
Packaging :
Approval Date :
Application Number : 203631
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LUMRYZ
Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL
Dosage Strength : 4.5GM/PACKET
Packaging :
Approval Date : 2023-05-01
Application Number : 214755
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LUMRYZ
Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL
Dosage Strength : 6GM/PACKET
Packaging :
Approval Date : 2023-05-01
Application Number : 214755
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LUMRYZ
Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL
Dosage Strength : 7.5GM/PACKET
Packaging :
Approval Date : 2023-05-01
Application Number : 214755
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LUMRYZ
Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL
Dosage Strength : 9GM/PACKET
Packaging :
Approval Date : 2023-05-01
Application Number : 214755
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Ukraine
Brand Name : Natrii oxybutyras
Dosage Form : Solution for Injection
Dosage Strength : 200MG/ML
Packaging : 5ML, 10ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info : Generic CTD
Registration Country : Latvia
Brand Name :
Dosage Form : INJECTION
Dosage Strength : 200MG/ML
Packaging : 10ml amp
Approval Date :
Application Number :
Regulatory Info : Generic CTD
Registration Country : Latvia
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM OXYBATE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 0.5GM/ML
Packaging :
Approval Date : 2017-01-17
Application Number : 202090
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : XYREM
Dosage Form : SOLUTION;ORAL
Dosage Strength : 0.5GM/ML
Packaging :
Approval Date : 2002-07-17
Application Number : 21196
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Brand Name : XYWAV
Dosage Form : SOLUTION;ORAL
Dosage Strength : 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML
Packaging :
Approval Date : 2020-07-21
Application Number : 212690
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Schedule G (CDSA I)
Registration Country : Canada
Brand Name : XYREM
Dosage Form : SOLUTION
Dosage Strength : 500MG/ML
Packaging : 180ML
Approval Date :
Application Number : 2268272
Regulatory Info : Schedule G (CDSA I)
Registration Country : Canada
Regulatory Info : Schedule G (CDSA I)
Registration Country : Canada
Brand Name : XYWAV
Dosage Form : SOLUTION
Dosage Strength : 0.04G/ML
Packaging :
Approval Date :
Application Number : 2538237
Regulatory Info : Schedule G (CDSA I)
Registration Country : Canada
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Solution
Dosage Strength : 500MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : USA
Brand Name : SODIUM OXYBATE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 500MG/ML
Packaging :
Approval Date :
Application Number : 203351
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Xyrem
Dosage Form : ORAL SOLUTION
Dosage Strength : 500 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Xyrem
Dosage Form : Solution
Dosage Strength : 500mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : Alcover
Dosage Form : Sodium Oxybate 17.5% 10Ml 12 Combined Oral Use
Dosage Strength : os soluz 12 vials 10 ml 17.5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Alcover
Dosage Form : Sodium Oxybate 17.5% 140Ml Oral Use
Dosage Strength : os soluz 140 ml 17.5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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