 Aspen API. More than just an API™
Aspen API. More than just an API™
 
										

 
				
									 
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01 7Aspen API
02 7Aspen Pharmacare Holdings
03 2medac
04 3Accure Labs
05 4Adienne
06 1Alvogen
07 1Amring Farma Srl
08 1Apotex Inc
09 1Eriochem S.A.
10 2Globela Pharma
11 1Ideogen Ag
12 1Macure Pharma
13 4Medartuum
14 4ORIFARM GROUP AS
15 2Paranova Pharmaceuticals Ab
16 1Sun Pharmaceutical Industries Limited
17 3TherDose Pharma
									 
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01 1Antic-calc Tablet, Film Coated
02 10Film Coated Tablet
03 2INJECTION
04 1Injection
05 6Injection/Infusion Solution
06 1Melphalan 2Mg 25 Units' Oral Use
07 1Melphalan 50Mg 10Ml 1 Units Parenteral Use
08 1Powder And Solvent For Infusion Solution
09 2Powder And Solvent For Injection And Infusion Solution
10 8Solution For Injection
11 1TAB
12 3TABLET
13 2TABLET;ORAL
14 3Tablet
15 2Tablets
16 1tablet
									 
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01 5Allowed
02 6Approved
03 3Authorized
04 2Cancelled
05 2DISCN
06 12Deregistered
07 4Generic
08 1Originator
09 1Prescription
10 9Blank
									 
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01 2ALKERAN
02 20Alkeran
03 1Alkeran 2 mg
04 1ERIOLAN
05 1MELPHALAN
06 1MELPHATHER
07 1Melfalan Aspen
08 1Melfalan Sun
09 1Melphalan Aspen
10 1Melphalan Breastfeeding
11 1Melphalan Ideogen
12 1Melphalan Macure
13 1Melphalan Medac
14 1Melphalan Medical
15 4Phelinun
16 7Blank
									 
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01 1Argentina
02 1Australia
03 1Canada
04 8India
05 2Italy
06 1Norway
07 1South Africa
08 5Spain
09 18Sweden
10 5Switzerland
11 2USA
Regulatory Info :
Registration Country : Italy
Brand Name : Alkeran
Dosage Form : Melphalan 2Mg 25 Units' Oral Use
Dosage Strength : 25 cpr riv 2 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Alkeran
Dosage Form : Film Coated Tablet
Dosage Strength : 2mg
Packaging :
Approval Date : 21/01/1965
Application Number : 19650121000014
Regulatory Info : Approved
Registration Country : Sweden
 medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Melphalan Medac
Dosage Form : Injection/Infusion Solution
Dosage Strength : 50mg
Packaging :
Approval Date : 17/06/2020
Application Number : 20190201000054
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Alkeran
Dosage Form : Melphalan 50Mg 10Ml 1 Units Parenteral Use
Dosage Strength : 1 vial EV 50 mg + 1 vial solv 10 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Alkeran
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 2 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Melphalan Aspen
Dosage Form : Powder And Solvent For Injection And Infusion Solution
Dosage Strength : 50MG
Packaging :
Approval Date : 1996-07-01
Application Number : 61063
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Alkeran
Dosage Form : Film Coated Tablet
Dosage Strength : 2MG
Packaging :
Approval Date : 2021-03-08
Application Number : 83765
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Alkeran
Dosage Form : Powder And Solvent For Infusion Solution
Dosage Strength : 50MG
Packaging :
Approval Date : 2021-03-08
Application Number : 83766
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Melfalan Aspen
Dosage Form : Tablet
Dosage Strength : 2MG
Packaging :
Approval Date : 1965-06-01
Application Number : 41137
Regulatory Info : Cancelled
Registration Country : Spain
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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Alkeran
Dosage Form : Film Coated Tablet
Dosage Strength : 2mg
Packaging :
Approval Date : 17/09/1964
Application Number : 30897
Regulatory Info : Allowed
Registration Country : Switzerland
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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Alkeran
Dosage Form : Injection/Infusion Solution
Dosage Strength : 50mg/10ml
Packaging :
Approval Date : 18/06/1993
Application Number : 52193
Regulatory Info : Allowed
Registration Country : Switzerland
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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Alkeran
Dosage Form : Solution For Injection
Dosage Strength : 50mg
Packaging :
Approval Date : 04/12/1992
Application Number : 19921204000147
Regulatory Info : Approved
Registration Country : Sweden
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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ALKERAN
Dosage Form : TABLET
Dosage Strength : 2MG
Packaging : 50
Approval Date :
Application Number : 4715
Regulatory Info : Prescription
Registration Country : Canada
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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Alkeran 2 mg
Dosage Form : TAB
Dosage Strength : 2mg
Packaging : 25X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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Regulatory Info :
Registration Country : Australia
Brand Name : Alkeran
Dosage Form : tablet
Dosage Strength : 2 mg
Packaging : 25
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
 medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Melphalan Medical
Dosage Form : Powder And Solvent For Injection And Infusion Solution
Dosage Strength : 50MG
Packaging :
Approval Date : 2021-05-10
Application Number : 85961
Regulatory Info : Cancelled
Registration Country : Spain
 
												 
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Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : INJECTION
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India

 
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Regulatory Info : DISCN
Registration Country : USA
Brand Name : MELPHALAN
Dosage Form : TABLET;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2017-03-22
Application Number : 207809
Regulatory Info : DISCN
Registration Country : USA

 
												 
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Regulatory Info : DISCN
Registration Country : USA
Brand Name : ALKERAN
Dosage Form : TABLET;ORAL
Dosage Strength : 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 14691
Regulatory Info : DISCN
Registration Country : USA

 
												 
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Regulatory Info : Generic
Registration Country : Argentina
Brand Name : ERIOLAN
Dosage Form : INJECTION
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number : 90303
Regulatory Info : Generic
Registration Country : Argentina
