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    Chemistry

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    Also known as: 298-59-9, Centedrin, Centedrine, Methylphenidate hcl, Concerta, Ritalin
    Molecular Formula
    C14H20ClNO2
    Molecular Weight
    269.77  g/mol
    InChI Key
    JUMYIBMBTDDLNG-UHFFFAOYSA-N
    Methylphenidate Hydrochloride
    A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.
    1 2D Structure

    Methylphenidate Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    methyl 2-phenyl-2-piperidin-2-ylacetate;hydrochloride
    2.1.2 InChI
    InChI=1S/C14H19NO2.ClH/c1-17-14(16)13(11-7-3-2-4-8-11)12-9-5-6-10-15-12;/h2-4,7-8,12-13,15H,5-6,9-10H2,1H3;1H
    2.1.3 InChI Key
    JUMYIBMBTDDLNG-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    COC(=O)C(C1CCCCN1)C2=CC=CC=C2.Cl
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Centedrin

    2. Concerta

    3. Daytrana

    4. Equasym

    5. Hydrochloride, Methylphenidate

    6. Metadate

    7. Methylin

    8. Methylphenidate

    9. Phenidylate

    10. Ritalin

    11. Ritalin Sr

    12. Ritalin-sr

    13. Ritaline

    14. Tsentedrin

    2.2.2 Depositor-Supplied Synonyms

    1. 298-59-9

    2. Centedrin

    3. Centedrine

    4. Methylphenidate Hcl

    5. Concerta

    6. Ritalin

    7. Methylphenidate.hcl

    8. Metadate

    9. Methylin

    10. Metilfenidat Hydrochloride

    11. Ritalin Sr

    12. H-tic-otbu.hcl

    13. Threo-methylphenidate Hydrochloride

    14. Daytrana

    15. Methylin Er

    16. Methylphenidylacetate Hydrochloride

    17. Ritalin La

    18. Methylphenidate (hydrochloride)

    19. Ritalin Hydrochloride

    20. Ritalin-sr

    21. Methyl 2-phenyl-2-piperidin-2-ylacetate;hydrochloride

    22. Nsc-169868

    23. Ncgc00091942-01

    24. Rilaline

    25. Dsstox_cid_886

    26. Dsstox_rid_75843

    27. Dsstox_gsid_20886

    28. Methyl Phenyl(piperidin-2-yl)acetate Hydrochloride

    29. Quillichew

    30. Quillivant

    31. Aptensio

    32. Foquest

    33. Meridil Hydrochloride

    34. Oros Mph

    35. Aptensio Xr

    36. Rilatine

    37. Quillivant Xr

    38. Quillichew Er

    39. Chebi:31836

    40. Cas-298-59-9

    41. Nsc 169868

    42. Ccris 6258

    43. Methyl 2-phenyl-2-(piperidin-2-yl)acetate Hydrochloride

    44. Einecs 206-065-3

    45. Spd544

    46. Spd-544

    47. Methylphenidate Hydrochloride Er

    48. Concerta (tn)

    49. Metadate (tn)

    50. Methyl Phenidate Hcl

    51. Ritalin (tn)

    52. Methyl Alpha-phenyl-2-piperidineacetate Hydrochloride

    53. Quillivant Xr (tn)

    54. Methylphenidate Hydrochloride [usp:jan]

    55. Methylphenidate(ritalin)

    56. Methyl .alpha.-phenyl-2-piperidineacetate Hydrochloride

    57. Chembl1722

    58. Schembl41067

    59. Mls003922100

    60. Dtxsid8020886

    61. Methylphenidate Hydrochloride Cii

    62. Hy-b1091a

    63. Pharmakon1600-01505907

    64. Bcp34044

    65. Tox21_111186

    66. Tox21_200309

    67. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride

    68. Mfcd00058191

    69. Nsc169868

    70. Nsc759278

    71. Akos016010356

    72. Ccg-213572

    73. Cs-4658

    74. Nsc-759278

    75. Sb13180

    76. Wln: T6mtj Byr & Vo1 & Gh

    77. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (r*,r*)-(+-)-

    78. Methylphenidate Hydrochloride (jan/usp)

    79. Ncgc00257863-01

    80. Smr000058998

    81. Ft-0672045

    82. Ft-0672046

    83. Ft-0672048

    84. Ft-0672050

    85. D01296

    86. 298m599

    87. 2-piperidineacetic Acid, Methyl Ester, Hydrochloride

    88. Methylphenidate Hydrochloride(ritalin Hydrochloride)

    89. Methylphenidate Hcl;threo-methylphenidate Hydrochloride

    90. Q26840773

    91. Methyl 2-phenyl-2-(piperidin-2-yl)acetate Hcl

    92. Methylphenidate Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    93. Methylphenidate Hydrochloride Solution, (racemic Mixture), Ampule Of 1 Ml, 1.0 Mg/ml In Methanol (as Free Base), Certified Reference Material

    2.3 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 269.77 g/mol
    Molecular Formula C14H20ClNO2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count4
    Exact Mass269.1182566 g/mol
    Monoisotopic Mass269.1182566 g/mol
    Topological Polar Surface Area38.3 Ų
    Heavy Atom Count18
    Formal Charge0
    Complexity249
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 16  
    Drug NameConcerta
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelCONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength54mg; 18mg; 27mg; 36mg
    Market StatusPrescription
    CompanyJanssen Pharms

    2 of 16  
    Drug NameMetadate cd
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 50mg; 60mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyUcb

    3 of 16  
    Drug NameMetadate er
    PubMed HealthMethylphenidate (By mouth)
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.Methylphenidate hydrochloride is m...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyUcb

    4 of 16  
    Drug NameMethylin er
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyMallinckrodt

    5 of 16  
    Drug NameMethylphenidate hydrochloride
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release; Tablet; Capsule, extended release; Solution
    Routeoral; Oral
    Strength10mg/5ml; 18mg; 30mg; 27mg; 36mg; 5mg; 54mg; 50mg; 60mg; 10mg; 5mg/5ml; 40mg; 20mg
    Market StatusTentative Approval; Prescription
    CompanyCorepharma; Vintage Pharms; Actavis Labs Fl; Sun Pharm Inds; Barr Labs; Mallinckrodt; Watson Labs; Actavis S Atlantic; Teva Pharms; Caraco; Ucb; Kudco Ireland; Tris Pharma

    6 of 16  
    Drug NameQuillivant xr
    Drug LabelQUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80%...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormFor suspension, extended release
    RouteOral
    Strength5mg/ml
    Market StatusPrescription
    CompanyNextwave Pharms

    7 of 16  
    Drug NameRitalin
    Drug LabelRitalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral admin...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    8 of 16  
    Drug NameRitalin la
    Drug LabelMethylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    9 of 16  
    Drug NameConcerta
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelCONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength54mg; 18mg; 27mg; 36mg
    Market StatusPrescription
    CompanyJanssen Pharms

    10 of 16  
    Drug NameMetadate cd
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 50mg; 60mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyUcb

    11 of 16  
    Drug NameMetadate er
    PubMed HealthMethylphenidate (By mouth)
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.Methylphenidate hydrochloride is m...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyUcb

    12 of 16  
    Drug NameMethylin er
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyMallinckrodt

    13 of 16  
    Drug NameMethylphenidate hydrochloride
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release; Tablet; Capsule, extended release; Solution
    Routeoral; Oral
    Strength10mg/5ml; 18mg; 30mg; 27mg; 36mg; 5mg; 54mg; 50mg; 60mg; 10mg; 5mg/5ml; 40mg; 20mg
    Market StatusTentative Approval; Prescription
    CompanyCorepharma; Vintage Pharms; Actavis Labs Fl; Sun Pharm Inds; Barr Labs; Mallinckrodt; Watson Labs; Actavis S Atlantic; Teva Pharms; Caraco; Ucb; Kudco Ireland; Tris Pharma

    14 of 16  
    Drug NameQuillivant xr
    Drug LabelQUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80%...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormFor suspension, extended release
    RouteOral
    Strength5mg/ml
    Market StatusPrescription
    CompanyNextwave Pharms

    15 of 16  
    Drug NameRitalin
    Drug LabelRitalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral admin...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    16 of 16  
    Drug NameRitalin la
    Drug LabelMethylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    4.2 Drug Indication

    Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Central Nervous System Stimulants

    A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)

    Dopamine Uptake Inhibitors

    Drugs that block the transport of DOPAMINE into axon terminals or into storage vesicles within terminals. Most of the ADRENERGIC UPTAKE INHIBITORS also inhibit dopamine uptake. (See all compounds classified as Dopamine Uptake Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Central Nervous System Stimulation [PE]; Central Nervous System Stimulant [EPC]

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    CEP 2017-119 - Rev 02
    Valid
    Chemical
    2026-03-03
    2235
    Veranova

    01

    VERANOVA, L.P. West Deptford US

    U.S.A
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    Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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    Methylphenidate Hydrochloride

    Certificate Number : CEP 2017-119 - Rev 02

    Status : Valid

    Issue Date : 2026-03-03

    Type : Chemical

    Substance Number : 2235

    Veranova

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    MACFARLAN SMITH LIMITED Edinburgh G...

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    Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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    Methylphenidate hydrochloride

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    R1-CEP 2009-078 - Rev 00
    Valid
    Chemical
    2015-01-27
    2235
    Veranova

    02

    MACFARLAN SMITH LIMITED Edinburgh G...

    U.S.A
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    Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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    Methylphenidate Hydrochloride

    Certificate Number : R1-CEP 2009-078 - Rev 00

    Status : Valid

    Issue Date : 2015-01-27

    Type : Chemical

    Substance Number : 2235

    Veranova

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    SCI PHARMTECH, INC. Taoyuan City TW

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    Virtual BoothSCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

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    Methylphenidate hydrochloride

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    R1-CEP 2012-168 - Rev 01
    Valid
    Chemical
    2022-09-09
    2235
    SCI Company Banner

    03

    SCI PHARMTECH, INC. Taoyuan City TW

    Taiwan
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    Virtual BoothSCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

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    Methylphenidate Hydrochloride

    Certificate Number : R1-CEP 2012-168 - Rev 01

    Status : Valid

    Issue Date : 2022-09-09

    Type : Chemical

    Substance Number : 2235

    SCI Company Banner

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    COHANCE LIFESCIENCES LIMITED Mumbai...

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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Methylphenidate hydrochloride

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    CEP 2017-181 - Rev 02
    Valid
    Chemical
    2024-12-05
    2235
    Cohance

    04

    COHANCE LIFESCIENCES LIMITED Mumbai...

    India
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Methylphenidate Hydrochloride

    Certificate Number : CEP 2017-181 - Rev 02

    Status : Valid

    Issue Date : 2024-12-05

    Type : Chemical

    Substance Number : 2235

    Cohance

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    NORAMCO, LLC. Wilmington US

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    Virtual BoothNoramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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    Methylphenidate hydrochloride

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    CEP 2018-030 - Rev 04
    Valid
    Chemical
    2024-09-26
    2235
    Noramco

    05

    NORAMCO, LLC. Wilmington US

    U.S.A
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    Virtual BoothNoramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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    Methylphenidate Hydrochloride

    Certificate Number : CEP 2018-030 - Rev 04

    Status : Valid

    Issue Date : 2024-09-26

    Type : Chemical

    Substance Number : 2235

    Noramco

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    SIEGFRIED EVIONNAZ SA Evionnaz CH

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    Virtual BoothSiegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.

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    Methylphenidate hydrochloride

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    R1-CEP 2011-378 - Rev 01
    Valid
    Chemical
    2018-10-19
    2235
    Company Banner

    06

    SIEGFRIED EVIONNAZ SA Evionnaz CH

    Switzerland
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    Virtual BoothSiegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.

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    Methylphenidate Hydrochloride

    Certificate Number : R1-CEP 2011-378 - Rev 01

    Status : Valid

    Issue Date : 2018-10-19

    Type : Chemical

    Substance Number : 2235

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    IPCA Laboratories Limited Mumbai IN

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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Methylphenidate hydrochloride

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    R1-CEP 2009-094 - Rev 00
    Valid
    Chemical
    2015-08-03
    2235
    blank

    07

    IPCA Laboratories Limited Mumbai IN

    India
    PEGS Boston Summit
    Not Confirmed
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    IPCA Laboratories Limited Mumbai IN

    India
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Methylphenidate Hydrochloride

    Certificate Number : R1-CEP 2009-094 - Rev 00

    Status : Valid

    Issue Date : 2015-08-03

    Type : Chemical

    Substance Number : 2235

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    SPECGX LLC Webster Groves US

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    Methylphenidate hydrochloride

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    R1-CEP 2009-140 - Rev 01
    Valid
    Chemical
    2018-02-06
    2235
    blank

    08

    SPECGX LLC Webster Groves US

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    SPECGX LLC Webster Groves US

    Ireland
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Methylphenidate Hydrochloride

    Certificate Number : R1-CEP 2009-140 - Rev 01

    Status : Valid

    Issue Date : 2018-02-06

    Type : Chemical

    Substance Number : 2235

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    LABORATORIOS RUBIO, S.A. Castellbis...

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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    R1-CEP 2016-073 - Rev 00
    Valid
    Chemical
    2022-03-08
    2235
    blank

    09

    LABORATORIOS RUBIO, S.A. Castellbis...

    Spain
    PEGS Boston Summit
    Not Confirmed
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    LABORATORIOS RUBIO, S.A. Castellbis...

    Spain
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    Methylphenidate Hydrochloride

    Certificate Number : R1-CEP 2016-073 - Rev 00

    Status : Valid

    Issue Date : 2022-03-08

    Type : Chemical

    Substance Number : 2235

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    Listed Suppliers

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    01

    Veranova

    U.S.A
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    Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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    Methylphenidate Hydrochloride

    About the Company : Veranova is a global leader in developing and manufacturing specialist and complex APIs for pharma and biotech customers, with over 50 years of experience supporting the healthcare...

    Veranova is a global leader in developing and manufacturing specialist and complex APIs for pharma and biotech customers, with over 50 years of experience supporting the healthcare industry and building trusted customer relationships. Operating in two divisions-Generics and Originators-it offers tailored services for every stage of the drug development lifecycle. Macfarlan Smith Limited trades as Veranova in the United Kingdom. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Veranova

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    02

    SCI Pharmtech

    Taiwan
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    Virtual BoothSCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

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    Methylphenidate Hydrochloride

    About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products with a focus on rapid development and cost-effective production. Its fully equipped research labs, pilot...

    SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products with a focus on rapid development and cost-effective production. Its fully equipped research labs, pilot plants, and production facilities ensure high-quality results. Collaborating globally, SCI Pharmtech creates key intermediates and APIs, meeting FDA, EDQM, and Taiwan TFDA standards for reliable, compliant, large-scale manufacturing. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    SCI Company Banner

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    03

    Cohance Lifesciences

    India
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Methylphenidate Hydrochloride

    About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...

    Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expertise in complex chemistries, we provide end-to-end CDMO solutions to global innovators. As a global API player, we serve customers in nearly 60 countries with 80+ molecules, supported by robust R&D, regulatory capabilities, and advanced manufacturing infrastructure, including strong backward-integrated pellet manufacturing. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Cohance

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    04

    Malladi Drugs & Pharmaceuticals Lim...

    India
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    Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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    Methylphenidate Hydrochloride

    About the Company : Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in th...

    Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in the cough and cold segment, with strong presence in antihistamines, anti-convulsants, anti-depressants, and anxiolytics. Malladi exports to around 60 countries, with over 85% revenue from exports, and its facilities are approved by FDA, EDQM, KFDA, TGA, and other agencies. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Malladi

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    05

    HRV Pharma

    India
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    Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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    Methylphenidate Hydrochloride

    About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

    HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    HRV Global Life Sciences

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    06

    Noramco

    U.S.A
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    Virtual BoothNoramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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    Methylphenidate Hydrochloride

    About the Company : Noramco, founded in 1979, specializes in developing and manufacturing APIs for opioid and non-opioid products. It excels in controlled substance development, offering supply-chain ...

    Noramco, founded in 1979, specializes in developing and manufacturing APIs for opioid and non-opioid products. It excels in controlled substance development, offering supply-chain integration, efficient API routes, analytical data, stability studies, regulatory support, formulation-friendly particle sizes, extended technical packages, DEA-compliant security, and scalable production from kilos to multi-tons. Noramco ensures world-class supply security for Schedule I to III controlled substances. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Noramco

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    07

    Curia

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

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    Methylphenidate Hydrochloride

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expe...

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    08

    Centaur Pharmaceuticals

    India
    PEGS Boston Summit
    Not Confirmed
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    Centaur Pharmaceuticals

    India
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Methylphenidate Hydrochloride

    About the Company : Centaur accepts change as a constant, and continuously innovates to remain significant. Centaur has built knowledge sharing relationships with the pharmaceutical majors in areas of...

    Centaur accepts change as a constant, and continuously innovates to remain significant. Centaur has built knowledge sharing relationships with the pharmaceutical majors in areas of product development, custom synthesis, contract research and contract manufacturing. Centaur formulations and API are exported across 5 continents and more than 60 countries including regulated markets. Centaur ranks among India's TOP 50 pharmaceutical companies by prescriptions (CMarc) and by stockist audit (ORG-IMS). Centaur's All-India network includes a 1000 strong sales force that covers 250,000 doctors and 250,000 retailers every month.
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    09

    Dishman Carbogen Amcis

    India
    PEGS Boston Summit
    Not Confirmed
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    Dishman Carbogen Amcis

    India
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Methylphenidate Hydrochloride

    About the Company : We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to m...

    We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to market while improving the lives of their patients across the world. Our objective is to help our customers create a better world as the partner of choice to develop and manufacture complex and challenging substances, highly potent active ingredients, and breaking new ground with innovative vitamin, healthcare, and industrial products.
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    10

    Harman Finochem

    India
    PEGS Boston Summit
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    Harman Finochem

    India
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    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Methylphenidate Hydrochloride

    About the Company : Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of ...

    Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of which 10 are Essential Drugs as per the WHO Model List. We deliver top quality products to more than 35 countries across the globe. Harman Finochem ensures that its customers worldwide are delighted by receiving APl’s which are safe, efficient and of highest quality. We adhere to principles of cGmp and our team at all levels is committed to achieving this corporate excellence goal.
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    Only 10 entries up to this point, click to access all click full view read-more
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    DRUG PRODUCT COMPOSITIONS

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    USFDA APPLICATION NUMBER - 18029

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    USFDA APPLICATION NUMBER - 202100

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    USFDA APPLICATION NUMBER - 207960

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    ABOUT THIS PAGE

    Looking for 298-59-9 / Methylphenidate Hydrochloride API manufacturers, exporters & distributors?

    Methylphenidate Hydrochloride manufacturers, exporters & distributors 1

    63

    PharmaCompass offers a list of Methylphenidate Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Methylphenidate Hydrochloride manufacturer or Methylphenidate Hydrochloride supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylphenidate Hydrochloride manufacturer or Methylphenidate Hydrochloride supplier.

    API | Excipient name

    Methylphenidate Hydrochloride

    Synonyms

    298-59-9, Centedrin, Centedrine, Methylphenidate hcl, Concerta, Ritalin

    Cas Number

    298-59-9

    About Methylphenidate Hydrochloride

    A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.

    Novartis Brand 1 of Methylphenidate Hydrochloride Manufacturers

    A Novartis Brand 1 of Methylphenidate Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Novartis Brand 1 of Methylphenidate Hydrochloride, including repackagers and relabelers. The FDA regulates Novartis Brand 1 of Methylphenidate Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Novartis Brand 1 of Methylphenidate Hydrochloride 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 Novartis Brand 1 of Methylphenidate Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

    Novartis Brand 1 of Methylphenidate Hydrochloride Suppliers

    A Novartis Brand 1 of Methylphenidate Hydrochloride supplier is an individual or a company that provides Novartis Brand 1 of Methylphenidate Hydrochloride active pharmaceutical ingredient (API) or Novartis Brand 1 of Methylphenidate Hydrochloride finished formulations upon request. The Novartis Brand 1 of Methylphenidate Hydrochloride suppliers may include Novartis Brand 1 of Methylphenidate Hydrochloride API manufacturers, exporters, distributors and traders.

    click here to find a list of Novartis Brand 1 of Methylphenidate Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

    Novartis Brand 1 of Methylphenidate Hydrochloride USDMF

    A Novartis Brand 1 of Methylphenidate Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Novartis Brand 1 of Methylphenidate Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Novartis Brand 1 of Methylphenidate Hydrochloride DMFs exist exist since differing nations have different regulations, such as Novartis Brand 1 of Methylphenidate Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Novartis Brand 1 of Methylphenidate Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Novartis Brand 1 of Methylphenidate Hydrochloride USDMF includes data on Novartis Brand 1 of Methylphenidate Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Novartis Brand 1 of Methylphenidate Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Novartis Brand 1 of Methylphenidate Hydrochloride suppliers with USDMF on PharmaCompass.

    Novartis Brand 1 of Methylphenidate Hydrochloride JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Novartis Brand 1 of Methylphenidate Hydrochloride Drug Master File in Japan (Novartis Brand 1 of Methylphenidate Hydrochloride JDMF) empowers Novartis Brand 1 of Methylphenidate Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Novartis Brand 1 of Methylphenidate Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Novartis Brand 1 of Methylphenidate Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Novartis Brand 1 of Methylphenidate Hydrochloride suppliers with JDMF on PharmaCompass.

    Novartis Brand 1 of Methylphenidate Hydrochloride KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Novartis Brand 1 of Methylphenidate Hydrochloride Drug Master File in Korea (Novartis Brand 1 of Methylphenidate Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Novartis Brand 1 of Methylphenidate Hydrochloride. The MFDS reviews the Novartis Brand 1 of Methylphenidate Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Novartis Brand 1 of Methylphenidate Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Novartis Brand 1 of Methylphenidate Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Novartis Brand 1 of Methylphenidate Hydrochloride API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Novartis Brand 1 of Methylphenidate Hydrochloride suppliers with KDMF on PharmaCompass.

    Novartis Brand 1 of Methylphenidate Hydrochloride CEP

    A Novartis Brand 1 of Methylphenidate Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Novartis Brand 1 of Methylphenidate Hydrochloride Certificate of Suitability (COS). The purpose of a Novartis Brand 1 of Methylphenidate Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Novartis Brand 1 of Methylphenidate Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Novartis Brand 1 of Methylphenidate Hydrochloride to their clients by showing that a Novartis Brand 1 of Methylphenidate Hydrochloride CEP has been issued for it. The manufacturer submits a Novartis Brand 1 of Methylphenidate Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Novartis Brand 1 of Methylphenidate Hydrochloride CEP holder for the record. Additionally, the data presented in the Novartis Brand 1 of Methylphenidate Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Novartis Brand 1 of Methylphenidate Hydrochloride DMF.

    A Novartis Brand 1 of Methylphenidate Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Novartis Brand 1 of Methylphenidate Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Novartis Brand 1 of Methylphenidate Hydrochloride suppliers with CEP (COS) on PharmaCompass.

    Novartis Brand 1 of Methylphenidate Hydrochloride WC

    A Novartis Brand 1 of Methylphenidate Hydrochloride written confirmation (Novartis Brand 1 of Methylphenidate Hydrochloride WC) is an official document issued by a regulatory agency to a Novartis Brand 1 of Methylphenidate Hydrochloride manufacturer, verifying that the manufacturing facility of a Novartis Brand 1 of Methylphenidate Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Novartis Brand 1 of Methylphenidate Hydrochloride APIs or Novartis Brand 1 of Methylphenidate Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Novartis Brand 1 of Methylphenidate Hydrochloride WC (written confirmation) as part of the regulatory process.

    click here to find a list of Novartis Brand 1 of Methylphenidate Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

    Novartis Brand 1 of Methylphenidate Hydrochloride NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Novartis Brand 1 of Methylphenidate Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Novartis Brand 1 of Methylphenidate Hydrochloride API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Novartis Brand 1 of Methylphenidate Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Novartis Brand 1 of Methylphenidate Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Novartis Brand 1 of Methylphenidate Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Novartis Brand 1 of Methylphenidate Hydrochloride suppliers with NDC on PharmaCompass.

    Novartis Brand 1 of Methylphenidate Hydrochloride GMP

    Novartis Brand 1 of Methylphenidate Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Novartis Brand 1 of Methylphenidate Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Novartis Brand 1 of Methylphenidate Hydrochloride GMP manufacturer or Novartis Brand 1 of Methylphenidate Hydrochloride GMP API supplier for your needs.

    Novartis Brand 1 of Methylphenidate Hydrochloride CoA

    A Novartis Brand 1 of Methylphenidate Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Novartis Brand 1 of Methylphenidate Hydrochloride's compliance with Novartis Brand 1 of Methylphenidate Hydrochloride specifications and serves as a tool for batch-level quality control.

    Novartis Brand 1 of Methylphenidate Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Novartis Brand 1 of Methylphenidate Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Novartis Brand 1 of Methylphenidate Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Novartis Brand 1 of Methylphenidate Hydrochloride EP), Novartis Brand 1 of Methylphenidate Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Novartis Brand 1 of Methylphenidate Hydrochloride USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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