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    Chemistry

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    Also known as: Depo-medrol, 53-36-1, M-predrol, Depo-medrate, Medrol acetate, Depo-medrone
    Molecular Formula
    C24H32O6
    Molecular Weight
    416.5  g/mol
    InChI Key
    PLBHSZGDDKCEHR-LFYFAGGJSA-N
    FDA UNII
    43502P7F0P
    Methylprednisolone Acetate
    Methylprednisolone derivative that is used as an anti-inflammatory agent for the treatment of ALLERGY and ALLERGIC RHINITIS; ASTHMA; and BURSITIS; and for the treatment of ADRENAL INSUFFICIENCY.
    1 2D Structure

    Methylprednisolone Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [2-[(6S,8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-6,10,13-trimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] acetate
    2.1.2 InChI
    InChI=1S/C24H32O6/c1-13-9-16-17-6-8-24(29,20(28)12-30-14(2)25)23(17,4)11-19(27)21(16)22(3)7-5-15(26)10-18(13)22/h5,7,10,13,16-17,19,21,27,29H,6,8-9,11-12H2,1-4H3/t13-,16-,17-,19-,21+,22-,23-,24-/m0/s1
    2.1.3 InChI Key
    PLBHSZGDDKCEHR-LFYFAGGJSA-N
    2.1.4 Canonical SMILES
    CC1CC2C3CCC(C3(CC(C2C4(C1=CC(=O)C=C4)C)O)C)(C(=O)COC(=O)C)O
    2.1.5 Isomeric SMILES
    C[C@H]1C[C@H]2[C@@H]3CC[C@@]([C@]3(C[C@@H]([C@@H]2[C@@]4(C1=CC(=O)C=C4)C)O)C)(C(=O)COC(=O)C)O
    2.2 Other Identifiers
    2.2.1 UNII
    43502P7F0P
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Acetyl Methylprednisolone

    2. Acetyl-methylprednisolone

    3. Depo Medrol

    4. Depo Medrone

    5. Depo-medrol

    6. Depo-medrone

    7. Methylprednisolone 21 Acetate

    8. Methylprednisolone Acetate, (11beta,16alpha)-isomer

    9. Methylprednisolone Acetate, (11beta,16beta)-isomer

    10. Methylprednisolone-21-acetate

    2.3.2 Depositor-Supplied Synonyms

    1. Depo-medrol

    2. 53-36-1

    3. M-predrol

    4. Depo-medrate

    5. Medrol Acetate

    6. Depo-medrone

    7. Methylprednisolone 21-acetate

    8. Depometicort

    9. Depomedrone

    10. Mepred

    11. Medrol Enpak

    12. Depo-medrin

    13. 6alpha-methylprednisolone Acetate

    14. D-med

    15. Urbason Crystal Suspension

    16. Depo-methylprednisolone Acetate

    17. 6alpha-methylprednisolone 21-acetate

    18. Depmedalone 40

    19. Depmedalone 80

    20. Methyl Prednisolone Acetate

    21. U 8210

    22. 11beta,17,21-trihydroxy-6alpha-methylpregna-1,4-diene-3,20-dione 21-acetate

    23. Nsc-48985

    24. 6alpha-methyl Prednisolone 21-acetate

    25. Chebi:6889

    26. Nsc 48985

    27. 43502p7f0p

    28. Depo-methylprednisolone

    29. Unidrol

    30. Lemod Depo

    31. (6alpha,11beta)-11,17-dihydroxy-6-methyl-3,20-dioxopregna-1,4-dien-21-yl Acetate

    32. Solsolona [inj.]

    33. Ubrason [inj.]

    34. [2-[(6s,8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-6,10,13-trimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Acetate

    35. Depot-medrol

    36. Solsolona

    37. Ubrason

    38. Mls002667229

    39. Einecs 200-171-3

    40. 6-methylprednisolone Acetate

    41. 6.alpha.-methylprednisolone Acetate

    42. Unii-43502p7f0p

    43. 6.alpha.-methylprednisolone 21-acetate

    44. Ncgc00159503-02

    45. Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6.alpha.,11.beta.)-

    46. Depo-medrol (tn)

    47. Methylprednisolone Acetate [usp:jan]

    48. Component Of Neo-medrol

    49. Dsstox_cid_3302

    50. Methylprednisolon-21-acetat

    51. Dsstox_rid_76966

    52. Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6-alpha,11-beta)-

    53. Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6alpha,11beta)-

    54. Dsstox_gsid_23302

    55. Schembl13231

    56. Mls001304003

    57. Methyl Prednisolone 21-acetate

    58. Chembl1364144

    59. Dtxsid7023302

    60. Methylprednisolone Ep Impurity J

    61. 11.beta.,17,21-trihydroxy-6.alpha.-methylpregna-1,4-diene-3,20-dione 21-acetate

    62. Bdbm233194

    63. Hms2233n14

    64. Hms3259l07

    65. Nsc48985

    66. 6?-methyl Prednisolone 21-acetate

    67. Tox21_111722

    68. S5973

    69. Methylprednisolone Acetate (jan/usp)

    70. Akos015969745

    71. Zinc118912449

    72. Nc00628

    73. 6 Alpha -methylprednisolone 21-acetate

    74. Cas-53-36-1

    75. Methylprednisolone Acetate [jan]

    76. Pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-6alpha-methyl-, 21-acetate

    77. Hy-13681

    78. Methylprednisolone Acetate [mart.]

    79. Methylprednisolone Acetate [vandf]

    80. Smr000718757

    81. Methylprednisolone Acetate [usp-rs]

    82. Methylprednisolone Acetate [who-dd]

    83. Cs-0007549

    84. M2635

    85. C08179

    86. D00979

    87. D87728

    88. Methylprednisolone Acetate [green Book]

    89. Methylprednisolone Acetate [orange Book]

    90. Ab00375925-05

    91. Methylprednisolone Acetate [ep Monograph]

    92. Methylprednisolone Acetate [usp Impurity]

    93. Methylprednisolone Acetate For Peak Identification

    94. Methylprednisolone Acetate For System Suitability

    95. 200m356

    96. Methylprednisolone Acetate [usp Monograph]

    97. Methylprednisolone Impurity J [ep Impurity]

    98. Methylprednisolone Acetate 100 Microg/ml In Methanol

    99. Q27107351

    100. Neo-medrol Acetate Component Methylprednisolone Acetate

    101. Methylprednisolone Acetate Component Of Neo-medrol Acetate

    102. Methylprednisolone Hydrogen Succinate Impurity C [ep Impurity]

    103. Pregna-1,20-dione, 11.beta.,17,21-trihydroxy-6.alpha.-methyl-, 21-acetate

    104. Pregna-1,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6.alpha.,11.beta.)-

    105. Methylprednisolone Acetate; 6?-methyl Prednisolone 21-acetate; Methylprednisolone Hydrogen Succinate Ep Impurity C; 11?,17-dihydroxy-6?-methyl-3,20-dioxopregna-1,4-dien21-yl Acetate; 21-acetoxy-11?,17-dihydroxy-6?-methylpregna-1,4-diene-3,20-dione

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 416.5 g/mol
    Molecular Formula C24H32O6
    XLogP32.7
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count4
    Exact Mass416.21988874 g/mol
    Monoisotopic Mass416.21988874 g/mol
    Topological Polar Surface Area101 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity858
    Isotope Atom Count0
    Defined Atom Stereocenter Count8
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameDepo-medrol
    Drug LabelDEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL; 40 mg/mL; 80 mg/mL.Each mL of these preparations contains:Methylprednisolone...
    Active IngredientMethylprednisolone acetate
    Dosage FormInjectable
    RouteInjection
    Strength20mg/ml; 80mg/ml; 40mg/ml
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    2 of 4  
    Drug NameMethylprednisolone acetate
    Drug LabelDEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL; 40 mg/mL; 80 mg/mL.Each mL of these preparations contains:Methylprednisolone...
    Active IngredientMethylprednisolone acetate
    Dosage FormInjectable
    RouteInjection
    Strength80mg/ml; 40mg/ml
    Market StatusPrescription
    CompanyTeva Pharms Usa; Sandoz

    3 of 4  
    Drug NameDepo-medrol
    Drug LabelDEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL; 40 mg/mL; 80 mg/mL.Each mL of these preparations contains:Methylprednisolone...
    Active IngredientMethylprednisolone acetate
    Dosage FormInjectable
    RouteInjection
    Strength20mg/ml; 80mg/ml; 40mg/ml
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    4 of 4  
    Drug NameMethylprednisolone acetate
    Drug LabelDEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL; 40 mg/mL; 80 mg/mL.Each mL of these preparations contains:Methylprednisolone...
    Active IngredientMethylprednisolone acetate
    Dosage FormInjectable
    RouteInjection
    Strength80mg/ml; 40mg/ml
    Market StatusPrescription
    CompanyTeva Pharms Usa; Sandoz

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Inflammatory Agents

    Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]

    API Reference Price

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PHARMACEUTICALS","customerCountry":"INDIA","quantity":"46.00","actualQuantity":"46","unit":"KGS","unitRateFc":"5000","totalValueFC":"231978.3","currency":"USD","unitRateINR":"423000","date":"08-Aug-2024","totalValueINR":"19458000","totalValueInUsd":"231978.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372900","bill_no":"4947046","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Sterile","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"VIA PAVIA, 1 GROPELLO CAIROLI, PV GROPELLO CAIROLI, PV 27027 IT","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723401000,"product":"METHYLPREDNISOLONE ACETATE STERILE MICRO","address":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB","city":"HYDERABAD,TELANGANA","supplier":"AXPLORA","supplierCountry":"ITALY","foreign_port":"MILANO","customer":"CRONUS PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"2.29","actualQuantity":"2291","unit":"GMS","unitRateFc":"7.5","totalValueFC":"17330.3","currency":"USD","unitRateINR":"634.5","date":"12-Aug-2024","totalValueINR":"1453639.5","totalValueInUsd":"17330.3","indian_port":"GMR HYDERABAD AVIATION-SEZ","hs_no":"29372900","bill_no":"5006186","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Sterile","supplierPort":"MILANO","supplierAddress":"VIA PAVIA 1 GROPELLO CAIROLI PV IT SDNF Italy","customerAddress":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726252200,"product":"METHYLPREDNISOLONE ACETATE USP","address":"18\/1 3 AZAMABAD","city":"HYDERABAD ,ANDHRA PRADESH","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"BIOLOGICAL E","customerCountry":"INDIA","quantity":"0.80","actualQuantity":"0.8","unit":"KGS","unitRateFc":"6500","totalValueFC":"5268.7","currency":"USD","unitRateINR":"551901.9","date":"14-Sep-2024","totalValueINR":"441521.5","totalValueInUsd":"5268.7","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"5610836","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"PARQUE TECNOLOGICO DE BOECILLO PARCELA 105 41751 CURIA BOECILLO VALLADOLID ES","customerAddress":"18\/1 3 AZAMABAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"METHYLPREDNISOLONE ACETATE MICRONIZED STERILE FOC ITEM BATCHNO.: W3211\/0 2306005","address":"PLOT No.30, GALAXY ,","city":"BENGALURU","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"STERISCIENCE SPECIALTIES PRIVATE ","customerCountry":"INDIA","quantity":"28.12","actualQuantity":"28.115","unit":"KGS","unitRateFc":"5500","totalValueFC":"159274.5","currency":"USD","unitRateINR":"476019.6","date":"26-Oct-2024","totalValueINR":"13383290.32","totalValueInUsd":"159274.5","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"6361915","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"PARQUE TECNOLOGICO DE BOECILLO PARCELA 105 47151 BOECILLO VALLADOLID SPAIN ES","customerAddress":"PLOT No.30, GALAXY ,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"METHYLPREDNISOLONE ACETATE MICRONIZED STERILE FOC ITEM BATCHNO.: W3211\/0 2306003","address":"PLOT No.30, GALAXY ,","city":"BENGALURU","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"STERISCIENCE SPECIALTIES PRIVATE ","customerCountry":"INDIA","quantity":"20.11","actualQuantity":"20.111","unit":"KGS","unitRateFc":"5500","totalValueFC":"113931","currency":"USD","unitRateINR":"476019.6","date":"28-Oct-2024","totalValueINR":"9573229.65","totalValueInUsd":"113931","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"6382432","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"PARQUE TECNOLOGICO DE BOECILLO PARCELA 105 47151 BOECILLO VALLADOLID SPAIN ES","customerAddress":"PLOT No.30, GALAXY ,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"METHYLPREDNISOLONE ACETATE MICRONIZED STERILE FOC ITEM BATCHNO.: W3211\/0 2306004","address":"PLOT No.30, GALAXY ,","city":"BENGALURU","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"STERISCIENCE SPECIALTIES PRIVATE ","customerCountry":"INDIA","quantity":"19.11","actualQuantity":"19.111","unit":"KGS","unitRateFc":"5500","totalValueFC":"108265.9","currency":"USD","unitRateINR":"476019.6","date":"28-Oct-2024","totalValueINR":"9097210.07","totalValueInUsd":"108265.9","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"6382432","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"PARQUE TECNOLOGICO DE BOECILLO PARCELA 105 47151 BOECILLO VALLADOLID SPAIN ES","customerAddress":"PLOT No.30, GALAXY ,"}]
    08-Feb-2021
    28-Oct-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

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    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INJECTION - 20MG/ML

    USFDA APPLICATION NUMBER - 11757

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    DOSAGE - INJECTABLE;INJECTION - 40MG/ML

    USFDA APPLICATION NUMBER - 11757

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    DOSAGE - INJECTABLE;INJECTION - 80MG/ML

    USFDA APPLICATION NUMBER - 11757

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    Excipients by Applications

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    Solubilizers

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    01

    Nanjing Well Pharmaceutical

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    BIO Partnering at JPM
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    • EDQM
    • WHO-GMP

    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Brand Name : Polysorbate 80

    Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

    Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.

    Pharmacopoeia Ref : ChP/USP/EP/JP

    Technical Specs : NA

    Ingredient(s) : Polysorbate 80

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    Nanjing Well Pharmaceutical

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    • fda
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet

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    Brand Name : Benzyl Alcohol

    Application : Parenteral, Solubilizers, Topical

    Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.

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    Nanjing Bold Chemical

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    BASF

    Germany
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    Finar

    India
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    Seppic

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    Nanjing Well Pharmaceutical

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    • fda
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

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    Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.

    Pharmacopoeia Ref : ChP/USP/EP/JP

    Technical Specs : NA

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    Nanjing Well Pharmaceutical

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    Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet

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    Brand Name : Benzyl Alcohol

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    Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.

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    Nanjing Well Pharmaceutical

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    Brand Name : Polyethylene Glycol 3350

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    Excipient Details : Polyethylene glycol 3350 is utilized in creams, lotions, ointments & gels. It is also used as a coating plasticizer & lubricant in tablets & capsules.

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    Nanjing Bold Chemical

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    Finar

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    Seppic

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    Actylis

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    Nanjing Well Pharmaceutical

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    Brand Name : Polysorbate 80

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    Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet

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    Brand Name : Benzyl Alcohol

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    Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.

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    Brand Name : Polyethylene Glycol 3350

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    Excipient Details : Polyethylene glycol 3350 is utilized in creams, lotions, ointments & gels. It is also used as a coating plasticizer & lubricant in tablets & capsules.

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    Nanjing Bold Chemical

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    Finar

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    Seppic

    France
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    08

    Gangwal Chemicals

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    Gangwal Chemicals

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    Brand Name : Polysorbate 80

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    USP

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    ABOUT THIS PAGE

    Methylprednisolone Acetate Manufacturers

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

    Methylprednisolone Acetate Suppliers

    A Methylprednisolone Acetate supplier is an individual or a company that provides Methylprednisolone Acetate active pharmaceutical ingredient (API) or Methylprednisolone Acetate finished formulations upon request. The Methylprednisolone Acetate suppliers may include Methylprednisolone Acetate API manufacturers, exporters, distributors and traders.

    click here to find a list of Methylprednisolone Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Methylprednisolone Acetate USDMF

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

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

    click here to find a list of Methylprednisolone Acetate suppliers with USDMF on PharmaCompass.

    Methylprednisolone Acetate CEP

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

    A Methylprednisolone Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Methylprednisolone Acetate 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 Methylprednisolone Acetate suppliers with CEP (COS) on PharmaCompass.

    Methylprednisolone Acetate WC

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

    click here to find a list of Methylprednisolone Acetate suppliers with Written Confirmation (WC) on PharmaCompass.

    Methylprednisolone Acetate 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 Methylprednisolone Acetate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Methylprednisolone Acetate 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 Methylprednisolone Acetate 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 Methylprednisolone Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methylprednisolone Acetate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Methylprednisolone Acetate suppliers with NDC on PharmaCompass.

    Methylprednisolone Acetate GMP

    Methylprednisolone Acetate 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 Methylprednisolone Acetate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Methylprednisolone Acetate GMP manufacturer or Methylprednisolone Acetate GMP API supplier for your needs.

    Methylprednisolone Acetate CoA

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

    Methylprednisolone Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Methylprednisolone Acetate 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.

    Methylprednisolone Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Methylprednisolone Acetate EP), Methylprednisolone Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methylprednisolone Acetate 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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