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Synopsis

Synopsis

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Chemistry

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Also known as: 1825352-65-5, Rg7916, Evrysdi, Ro7034067, Risdiplam [inn], Risdiplam [usan]
Molecular Formula
C22H23N7O
Molecular Weight
401.5  g/mol
InChI Key
ASKZRYGFUPSJPN-UHFFFAOYSA-N
FDA UNII
76RS4S2ET1

Risdiplam
Risdiplam is an orally bioavailable mRNA splicing modifier used for the treatment of spinal muscular atrophy (SMA). It increases systemic SMN protein concentrations by improving the efficiency of SMN2 gene transcription. This mechanism of action is similar to its predecessor [nusinersen], the biggest difference being their route of administration: nusinersen requires intrathecal administration, as does the one-time gene therapy [onasemnogene abeparvovec], whereas risdiplam offers the ease of oral bioavailability. Risdiplam was approved by the FDA in August 2020 for use in patients 2 months of age or older in the treatment of spinal muscular atrophy (SMA). Set to be substantially cheaper than other available SMA therapies, risdiplam appears to provide a novel and relatively accessible treatment option for patients with SMA regardless of severity or type.
1 2D Structure

Risdiplam

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
7-(4,7-diazaspiro[2.5]octan-7-yl)-2-(2,8-dimethylimidazo[1,2-b]pyridazin-6-yl)pyrido[1,2-a]pyrimidin-4-one
2.1.2 InChI
InChI=1S/C22H23N7O/c1-14-9-18(26-29-11-15(2)24-21(14)29)17-10-20(30)28-12-16(3-4-19(28)25-17)27-8-7-23-22(13-27)5-6-22/h3-4,9-12,23H,5-8,13H2,1-2H3
2.1.3 InChI Key
ASKZRYGFUPSJPN-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CC(=NN2C1=NC(=C2)C)C3=CC(=O)N4C=C(C=CC4=N3)N5CCNC6(C5)CC6
2.2 Other Identifiers
2.2.1 UNII
76RS4S2ET1
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 7-(4,7-diazaspiro(2.5)oct-7-yl)-2-(2,8-dimethylimidazo(1,2-b)pyridazin-6-yl)-4h-pyrido(1,2-a)pyrimidin-4-one

2.3.2 Depositor-Supplied Synonyms

1. 1825352-65-5

2. Rg7916

3. Evrysdi

4. Ro7034067

5. Risdiplam [inn]

6. Risdiplam [usan]

7. Rg-7916

8. 76rs4s2et1

9. Ro-7034067

10. 7-(4,7-diazaspiro[2.5]octan-7-yl)-2-(2,8-dimethylimidazo[1,2-b]pyridazin-6-yl)pyrido[1,2-a]pyrimidin-4-one

11. 2-(2,8-dimethylimidazo[1,2-b]pyridazin-6-yl)-7-(4,7-diazaspiro[2.5]octan-7-yl)-4h-pyrido[1,2-a]pyrimidin-4-one

12. 4h-pyrido(1,2-a)pyrimidin-4-one, 7-(4,7-diazaspiro(2.5)oct-7-yl)-2-(2,8-dimethylimidazo(1,2-b)pyridazin-6-yl)-

13. Evrysdi (tn)

14. Risdiplam; Rg7916

15. Risdiplam [jan]

16. Risdiplam [mi]

17. Risdiplam [usan:inn]

18. Risdiplam [who-dd]

19. Unii-76rs4s2et1

20. Risdiplam (jan/usan/inn)

21. Risdiplam [orange Book]

22. Chembl4297528

23. Schembl17260852

24. Gtpl11170

25. Dtxsid701109185

26. Amy23728

27. Ex-a2074

28. Mfcd31657372

29. Who 10614

30. Compound 1 [pmid: 30044619]

31. Db15305

32. Ac-36304

33. Br166842

34. Rg7916;ro7034067

35. Hy-109101

36. Cs-0039501

37. D11406

38. F53623

39. Q48969152

40. (7-(4,7-diazaspiro(2.5)octan-7-yl)-2-(2,8-dimethylimidazo(1,2-b)pyridazin-6-yl)pyrido(1,2-a)pyrimidin-4-one

41. 7-(4,7-diazaspiro(2.5)oct-7-yl)-2-(2,8-dimethylimidazo(1,2-b)pyridazin-6-yl)-4h-pyrido(1,2-a)pyrimidin-4-one

2.4 Create Date
2016-02-23
3 Chemical and Physical Properties
Molecular Weight 401.5 g/mol
Molecular Formula C22H23N7O
XLogP30.5
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count2
Exact Mass401.19640838 g/mol
Monoisotopic Mass401.19640838 g/mol
Topological Polar Surface Area78.1 Ų
Heavy Atom Count30
Formal Charge0
Complexity886
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Risdiplam is indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.


Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Risdiplam helps to alleviate symptoms of spinal muscular atrophy by stimulating the production of a critical protein in which these patients are deficient. Early trials with risdiplam demonstrated up to a 2-fold increase in SMN protein concentration in SMA patients after 12 weeks of therapy.


5.2 MeSH Pharmacological Classification

Neuromuscular Agents

Drugs used for their actions on skeletal muscle. Included are agents that act directly on skeletal muscle, those that alter neuromuscular transmission (NEUROMUSCULAR BLOCKING AGENTS), and drugs that act centrally as skeletal muscle relaxants (MUSCLE RELAXANTS, CENTRAL). Drugs used in the treatment of movement disorders are ANTI-DYSKINESIA AGENTS. (See all compounds classified as Neuromuscular Agents.)


5.3 ATC Code

M09AX10


M - Musculo-skeletal system

M09 - Other drugs for disorders of the musculo-skeletal system

M09A - Other drugs for disorders of the musculo-skeletal system

M09AX - Other drugs for disorders of the musculo-skeletal system

M09AX10 - Risdiplam


5.4 Absorption, Distribution and Excretion

Absorption

The Tmax following oral administration is approximately 1-4 hours. Following once-daily administration with a morning meal (or after breastfeeding), risdiplam reaches steady-state in approximately 7-14 days. The pharmacokinetics of risdiplam were found to be approximately linear between all studied dosages in patients with SMA.


Route of Elimination

Following the oral administration of 18mg risdiplam, approximately 53% of the dose was excreted in the feces and 28% was excreted in the urine. Unchanged parent drug comprised 14% of the dose excreted in feces and 8% of the dose excreted in urine.


Volume of Distribution

Following oral administration, risdiplam distributes well into the central nervous system and peripheral tissues. The apparent volume of distribution at steady-state is 6.3 L/kg.


Clearance

For a 14.9kg patient, the apparent clearance of risdiplam is 6.3 L/kg.


5.5 Metabolism/Metabolites

The metabolism of risdiplam is mediated primarily by flavin monooxygenases 1 and 3 (FMO1 and FMO3), with some involvement of CYP1A1, CYP2J2, CYP3A4, and CYP3A7. Parent drug comprises approximately 83% of circulating drug material. A pharmacologically-inactive metabolite, M1, has been identified as the major circulating metabolite - this M1 metabolite has been observed _in vitro_ to inhibit MATE1 and MATE2-K transporters, similar to the parent drug.


5.6 Biological Half-Life

The terminal elimination half-life of risdiplam is approximately 50 hours in healthy adults.


5.7 Mechanism of Action

Spinal muscular atrophy (SMA) is a severe and progressive congenital neuromuscular disease resulting from mutations in the survival of motor neuron 1 (_SMN1_) gene responsible for making SMN proteins. Clinical features of SMA include degeneration of motor neurons in the spinal cord which ultimately leads to muscular atrophy and, in some cases, loss of physical strength. SMN proteins are expressed ubiquitously throughout the body and are thought to hold diverse intracellular roles in DNA repair, cell signaling, endocytosis, and autophagy. A secondary _SMN_ gene (_SMN2_) can also produce SMN proteins, but a small nucleotide substitution in its sequence results in the exclusion of exon 7 during splicing in approximately 85% of the transcripts - this means that only ~15% of the SMN proteins produced by _SMN2_ are functional, which is insufficient to compensate for the deficits caused by _SMN1_ mutations. Emerging evidence suggests that many cells and tissues are selectively vulnerable to reduced SMN concentrations, making this protein a desirable target in the treatment of SMA. Risdiplam is an mRNA splicing modifier for _SMN2_ that increases the inclusion of exon 7 during splicing, which ultimately increases the amount of functional SMN protein produced by _SMN2_. It does so by binding to two sites in _SMN2_ pre-mRNA: the 5' splice site (5'ss) of intron 7 and the exonic splicing enhancer 2 (ESE2) of exon 7.


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Biophore India Pharmaceuticals Pvt...

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Metrochem API Private Limited

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Sinopep Pharmaceutical Inc

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DMF Number : 39602

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Natco Pharma Ltd

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Drugs in Development

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Details:

Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier, which is being evaluated for the treatment of infants with pre-symptomatic spinal muscular atrophy.


Lead Product(s): Risdiplam

Therapeutic Area: Genetic Disease Brand Name: Evrysdi

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Chugai Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 14, 2024

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F. Hoffmann-La Roche

Switzerland
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Switzerland
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Details : Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier, which is being evaluated for the treatment of infants with pre-symptomatic spinal muscular atrophy.

Brand Name : Evrysdi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 14, 2024

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Details:

Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier, which is being evaluated for the treatment of infants with pre-symptomatic spinal muscular atrophy.


Lead Product(s): Risdiplam

Therapeutic Area: Genetic Disease Brand Name: Evrysdi

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 15, 2024

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Details : Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier, which is being evaluated for the treatment of infants with pre-symptomatic spinal muscular atrophy.

Brand Name : Evrysdi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 15, 2024

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Details:

Under the agreement, Royalty Pharma acquires additional royalties on Evrysdi (risdiplam), a survival motor neuron 2 splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron protein deficiency.


Lead Product(s): Risdiplam

Therapeutic Area: Genetic Disease Brand Name: Evrysdi

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Royalty Pharma

Deal Size: $1,500.0 million Upfront Cash: $1,000.0 million

Deal Type: Agreement October 19, 2023

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Details : Under the agreement, Royalty Pharma acquires additional royalties on Evrysdi (risdiplam), a survival motor neuron 2 splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron protein deficiency.

Brand Name : Evrysdi

Molecule Type : Small molecule

Upfront Cash : $1,000.0 million

October 19, 2023

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Details:

Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency, which is used for babies under two months old with spinal muscular atrophy.


Lead Product(s): Risdiplam

Therapeutic Area: Genetic Disease Brand Name: Evrysdi

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 04, 2023

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Genentech

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Genentech

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Details : Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency, which is used for babies under two months old with spinal mu...

Brand Name : Evrysdi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 04, 2023

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Details:

Evrysdi (risdiplam) is the only non-invasive spinal muscular atrophy therapy approved to treat people of all ages in the European Union now including babies from birth, Approval was based on interim data from ongoing RAINBOWFISH trial.


Lead Product(s): Risdiplam

Therapeutic Area: Genetic Disease Brand Name: Evrysdi

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 29, 2023

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F. Hoffmann-La Roche

Switzerland
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Details : Evrysdi (risdiplam) is the only non-invasive spinal muscular atrophy therapy approved to treat people of all ages in the European Union now including babies from birth, Approval was based on interim data from ongoing RAINBOWFISH trial.

Brand Name : Evrysdi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 29, 2023

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Details:

Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency, which is used for babies under two months old with spinal muscular atrophy.


Lead Product(s): Risdiplam

Therapeutic Area: Genetic Disease Brand Name: Evrysdi

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 29, 2023

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F. Hoffmann-La Roche

Switzerland
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F. Hoffmann-La Roche

Switzerland
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Details : Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency, which is used for babies under two months old with spinal mu...

Brand Name : Evrysdi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 29, 2023

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Details:

Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency.


Lead Product(s): Risdiplam

Therapeutic Area: Genetic Disease Brand Name: Evrysdi

Study Phase: Phase IVProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2023

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F. Hoffmann-La Roche

Switzerland
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F. Hoffmann-La Roche

Switzerland
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Details : Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency.

Brand Name : Evrysdi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 21, 2023

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Details:

Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency.


Lead Product(s): Risdiplam

Therapeutic Area: Genetic Disease Brand Name: Evrysdi

Study Phase: Phase IVProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2023

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F. Hoffmann-La Roche

Switzerland
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Not Confirmed

F. Hoffmann-La Roche

Switzerland
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SupplySide West 2024
Not Confirmed

Details : Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency.

Brand Name : Evrysdi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 30, 2023

blank

Details:

Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency.


Lead Product(s): Risdiplam

Therapeutic Area: Genetic Disease Brand Name: Evrysdi

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 20, 2023

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F. Hoffmann-La Roche

Switzerland
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SupplySide West 2024
Not Confirmed

F. Hoffmann-La Roche

Switzerland
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SupplySide West 2024
Not Confirmed

Details : Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency.

Brand Name : Evrysdi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 20, 2023

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Details:

The study showed Evrysdi (risdiplam) led to a two-fold increase in median SMN protein levels versus baseline after 4 weeks of treatment in all patient groups, irrespective of previous treatment.


Lead Product(s): Risdiplam

Therapeutic Area: Genetic Disease Brand Name: Evrysdi

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 12, 2022

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F. Hoffmann-La Roche

Switzerland
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Not Confirmed

F. Hoffmann-La Roche

Switzerland
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Not Confirmed

Details : The study showed Evrysdi (risdiplam) led to a two-fold increase in median SMN protein levels versus baseline after 4 weeks of treatment in all patient groups, irrespective of previous treatment.

Brand Name : Evrysdi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 12, 2022

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INTERMEDIATES SUPPLIERS

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LinkChem

China
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LinkChem

China
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CAS Number : 1449598-85-9

End Use API : Risdiplam

About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

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LinkChem

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LinkChem

China
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CAS Number : 674792-08-6

End Use API : Risdiplam

About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

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LinkChem

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LinkChem

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CAS Number : 1825352-86-0

End Use API : Risdiplam

About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

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FDF Dossiers

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F. Hoffmann-La Roche

Switzerland
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F. Hoffmann-La Roche

Switzerland
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RISDIPLAM

Brand Name : EVRYSDI

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 0.75MG/ML

Packaging :

Approval Date :

Application Number : 2514931

Regulatory Info : Prescription

Registration Country : Canada

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F. Hoffmann-La Roche

Switzerland
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F. Hoffmann-La Roche

Switzerland
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risdiplam

Brand Name : Evrysdi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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F. Hoffmann-La Roche

Switzerland
PODD Partnership
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F. Hoffmann-La Roche

Switzerland
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PODD Partnership
Not Confirmed

risdiplam

Brand Name : Evrysdi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

F. Hoffmann-La Roche

Switzerland
PODD Partnership
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
PODD Partnership
Not Confirmed

risdiplam

Brand Name : Evrysdi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

05

F. Hoffmann-La Roche

Switzerland
PODD Partnership
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
PODD Partnership
Not Confirmed

risdiplam

Brand Name : Evrysdi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

06

F. Hoffmann-La Roche

Switzerland
PODD Partnership
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
PODD Partnership
Not Confirmed

risdiplam

Brand Name : Evrysdi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

07

F. Hoffmann-La Roche

Switzerland
PODD Partnership
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
PODD Partnership
Not Confirmed

risdiplam

Brand Name : Evrysdi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

08

F. Hoffmann-La Roche

Switzerland
PODD Partnership
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
PODD Partnership
Not Confirmed

risdiplam

Brand Name : Evrysdi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

09

F. Hoffmann-La Roche

Switzerland
PODD Partnership
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
PODD Partnership
Not Confirmed

risdiplam

Brand Name : Evrysdi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

10

F. Hoffmann-La Roche

Switzerland
PODD Partnership
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
PODD Partnership
Not Confirmed

risdiplam

Brand Name : Evrysdi

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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FDA Orange Book

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01

PODD Partnership
Not Confirmed
arrow
arrow
PODD Partnership
Not Confirmed

RISDIPLAM

Brand Name : EVRYSDI

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 0.75MG/ML

Approval Date : 2020-08-07

Application Number : 213535

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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