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    Chemistry

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    Also known as: Frisium, Urbanyl, Chlorepin, Clorepin, Urbadan, 22316-47-8
    Molecular Formula
    C16H13ClN2O2
    Molecular Weight
    300.74  g/mol
    InChI Key
    CXOXHMZGEKVPMT-UHFFFAOYSA-N
    FDA UNII
    2MRO291B4U
    Clobazam
    A benzodiazepine derivative that is a long-acting GABA-A RECEPTOR agonist. It is used as an antiepileptic in the treatment of SEIZURES, including seizures associated with LENNOX-GASTAUT SYNDROME. It is also used as an anxiolytic, for the short-term treatment of acute ANXIETY.
    Clobazam is a Benzodiazepine. The mechanism of action of clobazam is as a Cytochrome P450 2D6 Inhibitor, and Cytochrome P450 3A4 Inducer.
    1 2D Structure

    Clobazam

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    7-chloro-1-methyl-5-phenyl-1,5-benzodiazepine-2,4-dione
    2.1.2 InChI
    InChI=1S/C16H13ClN2O2/c1-18-13-8-7-11(17)9-14(13)19(16(21)10-15(18)20)12-5-3-2-4-6-12/h2-9H,10H2,1H3
    2.1.3 InChI Key
    CXOXHMZGEKVPMT-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN1C(=O)CC(=O)N(C2=C1C=CC(=C2)Cl)C3=CC=CC=C3
    2.2 Other Identifiers
    2.2.1 UNII
    2MRO291B4U
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1-phenyl-5-methyl-8-chloro-1,2,4,5- Tetrahydro-2,4-diketo-3h-1,5-benzodiazepine

    2. Frisium

    3. Hr 376

    4. Lm 2717

    5. Lm-2717

    6. Lm2717

    7. Onfi

    8. Urbanyl

    2.3.2 Depositor-Supplied Synonyms

    1. Frisium

    2. Urbanyl

    3. Chlorepin

    4. Clorepin

    5. Urbadan

    6. 22316-47-8

    7. Onfi

    8. Lm-2717

    9. Hr 376

    10. Clobazamum

    11. Mystan

    12. Lm 2717

    13. H-4723

    14. Ru-4723

    15. H 4723

    16. 1h-1,5-benzodiazepine-2,4(3h,5h)-dione, 7-chloro-1-methyl-5-phenyl-

    17. 7-chloro-1-methyl-5-phenyl-1h-1,5-benzodiazepine-2,4(3h,5h)-dione

    18. Hr-376

    19. 7-chloro-1-methyl-5-phenyl-1,5-benzodiazepine-2,4-dione

    20. Nsc 336279

    21. 1-phenyl-5-methyl-8-chloro-1,2,4,5-tetrahydro-2,4-dioxo-3h-1,5-benzodiazepine

    22. Chebi:31413

    23. 7-chloro-1-methyl-5-phenyl-1h-1,5-benzodiazepine-2,4-(3h,5h)-dione

    24. Nsc-336279

    25. 2mro291b4u

    26. Nsc336279

    27. Ncgc00168249-01

    28. Caastilium

    29. Noiafren

    30. Urbanil

    31. Odipam

    32. Clobazamum [inn-latin]

    33. Clobazepam

    34. 7-chloro-1-methyl-5-phenyl-1,5-dihydro-benzo[b][1,4]diazepine-2,4-dione

    35. 7-chloro-1-methyl-5-phenyl-2,3,4,5-tetrahydro-1h-1,5-benzodiazepine-2,4-dione

    36. Mystan (tn)

    37. Ccris 7506

    38. Einecs 244-908-7

    39. Brn 0758410

    40. Unii-2mro291b4u

    41. Clobazam (jan/usan/inn)

    42. Clobazam [usan:inn:ban]

    43. Colbazam

    44. Perizam

    45. Tapclob

    46. Urbanol

    47. Dea No. 2751

    48. Sympazan

    49. Onfi (tn)

    50. Clobazam [usan]

    51. Clobazam [inn]

    52. Clobazam [jan]

    53. Clobazam [mi]

    54. Clobazam [vandf]

    55. Colbazam [vandf]

    56. Clobazam [mart.]

    57. Clobazam [who-dd]

    58. 1-phenyl-5-methyl-8-chloro-1,2,4,5-tetrahydro-2,4-diketo-3h-1,5-benzodiazepine

    59. Dsstox_cid_26759

    60. Dsstox_rid_81883

    61. Dsstox_gsid_46759

    62. Schembl43038

    63. 5-24-08-00034 (beilstein Handbook Reference)

    64. Mls003899217

    65. Chembl70418

    66. Clobazam [orange Book]

    67. Gtpl7149

    68. Zinc1175

    69. Clobazam [ep Monograph]

    70. Dtxsid2046759

    71. Hsdb 8343

    72. Clobazam 0.1 Mg/ml In Methanol

    73. Clobazam 1.0 Mg/ml In Methanol

    74. Hy-a0041

    75. Tox21_112608

    76. Bdbm50247888

    77. Akos025401921

    78. Cs-6756

    79. Db00349

    80. Smr000058811

    81. Wln: T67 Gnv Jvn Ihj Cg G1 Kr

    82. Cas-22316-47-8

    83. Db-045870

    84. C-2991

    85. D01253

    86. Q412164

    87. Sr-01000937603

    88. Sr-01000937603-2

    89. 7-chloro-1-methyl-5-phenyl-1h-1,4(3h,5h)-dione

    90. 7-chloro-1-methyl-5-phenyl-1h-1,4-(3h,5h)-dione

    91. 1h-1,4(3h,5h)-dione, 7-chloro-1-methyl-5-phenyl-

    92. 7-chloro-1-methyl-5-phenyl-1,5-benzodiazepine-2,4(3h)-dione

    93. 1-phenyl 5-methyl 8-chloro 1,2,4,5-tetrahydo 2,4-dioxo 3h-1,5-benzodiazepine

    94. 1-phenyl 5-methyl 8-chloro 1,2,4,5-tetrahydro 2,4-dioxo 3h-1,5-benzodiazepine

    95. 1-phenyl-5-methyl-8-chloro-1,2,4,5-tetrahydro-2,4-dioxo-3h-1, 5-benzodiazepine

    96. 1-phenyl-5-methyl-8-chloro-1,4,5-tetrahydro-2,4-dioxo-3h-1,5-benzodiazepine

    97. Clobazam Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 300.74 g/mol
    Molecular Formula C16H13ClN2O2
    XLogP32.1
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count1
    Exact Mass300.0665554 g/mol
    Monoisotopic Mass300.0665554 g/mol
    Topological Polar Surface Area40.6 Ų
    Heavy Atom Count21
    Formal Charge0
    Complexity423
    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 Information
    1 of 2  
    Drug NameOnfi
    PubMed HealthClobazam (By mouth)
    Drug ClassesAnticonvulsant, Sedative-Hypnotic
    Drug LabelTable 4. Description Proprietary Name: ONFI Established Name: Clobazam Dosage Forms: Tablet and Oral Suspension Route of Administration: Oral Established Pharmacologic Class of Drug: Benzodiazepine Chemical Name:...
    Active IngredientClobazam
    Dosage FormTablet; Suspension
    RouteOral
    Strength2.5mg/ml; 10mg; 20mg
    Market StatusPrescription
    CompanyLundbeck

    2 of 2  
    Drug NameOnfi
    PubMed HealthClobazam (By mouth)
    Drug ClassesAnticonvulsant, Sedative-Hypnotic
    Drug LabelTable 4. Description Proprietary Name: ONFI Established Name: Clobazam Dosage Forms: Tablet and Oral Suspension Route of Administration: Oral Established Pharmacologic Class of Drug: Benzodiazepine Chemical Name:...
    Active IngredientClobazam
    Dosage FormTablet; Suspension
    RouteOral
    Strength2.5mg/ml; 10mg; 20mg
    Market StatusPrescription
    CompanyLundbeck

    4.2 Therapeutic Uses

    Anticonvulsants

    National Library of Medicine's Medical Subject Headings. Clobazam. Online file (MeSH, 2016). Available from, as of June 24, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Clobazam is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of July 6, 2016: https://clinicaltrials.gov/search/intervention=CLOBAZAM

    Onfi (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Onfi (Clobazam) Tablet; Onfi (Clobazam) Suspension (Updated: December 2014). Available from, as of July 1, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de03bd69-2dca-459c-93b4-541fd3e9571c

    Clobazam currently is FDA-labeled only for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. However, the drug has demonstrated broad anticonvulsant activity and has been used extensively in adults and pediatric patients with a wide range of other seizure disorders, which have sometimes been refractory, including partial, generalized, and myoclonic seizures. /NOT included in US product label/

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2294

    Clobazam has been used in the treatment of anxiety disorders and has been labeled for the short-term (2-4 weeks) treatment of anxiety in some countries outside the US. However, the drug currently is not FDA-labeled for the treatment of anxiety disorders in the US. /NOT included in US product label/

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2294

    4.3 Drug Warning

    Since clobazam has a CNS depressant effect, patients or their caregivers should be cautioned against concomitant use of other CNS depressant drugs or alcohol, and cautioned that the effects of other CNS depressants or alcohol may be potentiated.

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2295

    Somnolence and sedation are among the most common adverse effects associated with clobazam therapy. These effects generally begin within the first month of treatment and may diminish with continued therapy. In a placebo-controlled study of patients with Lennox-Gastaut syndrome, somnolence or sedation was reported in 26% of patients who received clobazam compared with 15% of those who received placebo. Somnolence and sedation were observed at all effective dosages in clinical trials and were dose related. The sedative effect of clobazam is reportedly less pronounced than that of other commercially available benzodiazepines

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2295

    Withdrawal symptoms (e.g., convulsions, psychosis, hallucinations, behavioral disorders, tremor, anxiety, irritability, dysphoria, insomnia, headache, palpitations, diarrhea) have been reported following abrupt discontinuance of benzodiazepines, including clobazam; the risk of withdrawal symptoms is greater with increasing dosage and duration of treatment. Such withdrawal reactions occur in patients who have developed physical dependence on these drugs. More severe withdrawal symptoms usually are limited to patients who abruptly discontinue therapy after receiving excessive dosages of benzodiazepines for an extended period of time. Milder withdrawal symptoms (e.g., dysphoria, anxiety, insomnia) generally have been reported following abrupt discontinuance of benzodiazepines in patients continuously receiving therapeutic dosages for several months.

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2295

    Abrupt discontinuance and rapid dosage reduction of clobazam should be avoided to minimize the risk of precipitating or exacerbating seizures, status epilepticus, and withdrawal symptoms. When therapy is discontinued, dosage of the drug should be decreased gradually (i.e., by 5-10 mg daily at weekly intervals).

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2295

    For more Drug Warnings (Complete) data for Clobazam (21 total), please visit the HSDB record page.

    4.4 Drug Indication

    For treatment and management of epilepsy and seizures associated with Lennox-Gastaut syndrome, a difficult-to-treat form of childhood epilepsy.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Similar to other benzodiazepines, clobazam binds to the interface of the and 2-subunit of the GABA-A receptor. However, it is considered a partial agonist to GABA-A receptors which sets clobazam apart from 1,4-benzodiazepines which are full agonist. The significance of this difference is that one may experience less sedation with clobazam than with other benzodiazepines. Unlike the endogenous GABA ligand, clobazam binds allosterically to the GABA receptor to increase the frequency of the chloride channel opening and membrane permeability to chloride ions. Pharmacodynamic tolerance has been demonstrated in animal models.

    5.2 MeSH Pharmacological Classification

    Anticonvulsants

    Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)

    Anti-Anxiety Agents

    Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)

    GABA-A Receptor Agonists

    Endogenous compounds and drugs that bind to and activate GABA-A RECEPTORS. (See all compounds classified as GABA-A Receptor Agonists.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    CLOBAZAM
    5.3.2 FDA UNII
    2MRO291B4U
    5.3.3 Pharmacological Classes
    Benzodiazepines [CS]; Cytochrome P450 2D6 Inhibitors [MoA]; Cytochrome P450 3A4 Inducers [MoA]; Benzodiazepine [EPC]
    5.4 ATC Code

    N05BA09

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    N - Nervous system

    N05 - Psycholeptics

    N05B - Anxiolytics

    N05BA - Benzodiazepine derivatives

    N05BA09 - Clobazam

    5.5 Absorption, Distribution and Excretion

    Absorption

    After oral administration of clobazam, it is almost completely absorbed (87% of dose). Bioavailability relative to solution was almost at 100%. Food does not affect absorption. Tmax = 1-3 hours.

    Route of Elimination

    Clobazam is eliminated via the urine (~94%) as metabolites.

    Volume of Distribution

    Vdss = 100 L. This high volume of distribution suggests extensive distribution to body tissues.

    Clearance

    Median estimated clearance = 2.49 L/h

    /MILK/ Onfi is excreted in human milk.

    NIH; DailyMed. Current Medication Information for Onfi (Clobazam) Tablet; Onfi (Clobazam) Suspension (Updated: December 2014). Available from, as of July 1, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de03bd69-2dca-459c-93b4-541fd3e9571c

    /MILK/ After oral administration of (14)C-clobazam (NH-15,7- chloro-1-methyl-5-phenyl-1H-1,5-benzodiazepine-2,4-(3H,5H)-dione) (4 mg/kg) to pregnant and lactating rats, the placental transfer and the secretion of radioactivity into milk were studied. Whole body autoradiograms of pregnant rats showed that radioactivity was distributed to the whole body of the fetus. Concentrations of radioactivity in fetal brain and blood were lower than the maternal plasma and placental levels, and decreased rapidly. The extent of transfer of radioactivity into the fetus reached maximum at 30 min after administration, amounting to 0.10% of the radioactivity administered per fetus. The composition of clobazam and its metabolites in plasma of pregnant rats at 30 min after oral administration was similar to that of non-pregnant rats. Concentration of radioactivity in the milk was 1.4 times higher than that in the blood, reached maximum 30 min after administration, then declined rapidly. The radioactivity transferred to the suckling via milk reached a maximum of 0.023% of the dose up to 8 hr after administration. Excretion of radioactivity from the suckling was slow. The composition of clobazam and its metabolites in aggregated milk in the suckling stomach was similar to that of female rat plasma.

    Yokoyama N et al; Iyakuhin Kenkyu 25 (8): 640-7 (1994)

    Clobazam is lipophilic and distributes rapidly throughout the body. The apparent volume of distribution at steady state was approximately 100 L. The in vitro plasma protein binding of clobazam and N-desmethylclobazam is approximately 80-90% and 70%, respectively.

    NIH; DailyMed. Current Medication Information for Onfi (Clobazam) Tablet; Onfi (Clobazam) Suspension (Updated: December 2014). Available from, as of July 1, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de03bd69-2dca-459c-93b4-541fd3e9571c

    Clobazam is rapidly and extensively absorbed following oral administration. The time to peak concentrations (Tmax) of clobazam tablets under fasted conditions ranged from 0.5 to 4 hours after single- or multiple-dose administrations. The relative bioavailability of clobazam tablets compared to an oral solution is approximately 100%. After single dose administration of the oral suspension under fasted conditions, the Tmax ranged from 0.5 to 2 hours. Based on exposure (Cmax and AUC) of clobazam, Onfi tablets and suspension were shown to have similar bioavailability under fasted conditions. The administration of Onfi tablets with food or when crushed in applesauce does not affect absorption. Although not studied, the oral bioavailability of the oral suspension is unlikely to be affected under fed conditions.

    NIH; DailyMed. Current Medication Information for Onfi (Clobazam) Tablet; Onfi (Clobazam) Suspension (Updated: December 2014). Available from, as of July 1, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de03bd69-2dca-459c-93b4-541fd3e9571c

    5.6 Metabolism/Metabolites

    Clobazam is extensively metabolized in the liver via N-demethylation and hydroxylation to form two major metabolites, N-desmethylclobazam (norclobazam) and 4'-hydroxyclobazam, respectively. N-desmethylclobazam (norclobazam) retains pharmacological activity. Norclobazam is one-fourth the potency of clobazam. The main enzyme that facilitates the process of N-demethylation is CYP3A4, and to a lesser extent by CYP2C19 and CYP2B6. Norclobazam itself is also metabolized via hydroxylation, primarily by CYP2C19. The formation of 4'-hydroxyclobazam is facilitated by CYP2C18 and CYP2C19. A factor in determining extent of metabolism is the genetic profile of the individual patient as CYP2C19 is a polymorphic enzyme.

    The polymorphic CYP2C19 is the major contributor to the metabolism of the pharmacologically active N-desmethylclobazam. In CYP2C19 poor metabolizers, levels of N-desmethylclobazam were 5-fold higher in plasma and 2- to 3-fold higher in the urine than in CYP2C19 extensive metabolizers.

    NIH; DailyMed. Current Medication Information for Onfi (Clobazam) Tablet; Onfi (Clobazam) Suspension (Updated: December 2014). Available from, as of July 1, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de03bd69-2dca-459c-93b4-541fd3e9571c

    Clobazam is extensively metabolized in the liver, with approximately 2% of the dose recovered in urine and 1% in feces as unchanged drug. The major metabolic pathway of clobazam involves N-demethylation, primarily by CYP3A4 and to a lesser extent by CYP2C19 and CYP2B6. N-desmethylclobazam, an active metabolite, is the major circulating metabolite in humans, and at therapeutic doses, plasma concentrations are 3-5 times higher than those of the parent compound. Based on animal and in vitro receptor binding data, estimates of the relative potency of N-desmethylclobazam compared to parent compound range from 1/5 to equal potency. N-desmethylclobazam is extensively metabolized, mainly by CYP2C19. N-desmethylclobazam and its metabolites comprise approximately 94% of the total drug-related components in urine. Following a single oral dose of radiolabeled drug, approximately 11% of the dose was excreted in the feces and approximately 82% was excreted in the urine.

    NIH; DailyMed. Current Medication Information for Onfi (Clobazam) Tablet; Onfi (Clobazam) Suspension (Updated: December 2014). Available from, as of July 1, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de03bd69-2dca-459c-93b4-541fd3e9571c

    A four-year-old male with symptomatic generalized epilepsy presented with ataxia, eye rolling, and episodes of back arching which were of non-epileptic origin following the introduction of clobazam at 0.75 mg/kg/day. Concurrent antiepileptic medication was lamotrigine at 13 mg/kg/day. Clobazam plasma levels were within the normal range, while N-desmethylclobazam (DCLB) concentrations were between five and seven times above the upper limit of the normal range. The plasma elimination half-life for DCLB was prolonged, suggesting a genetic variability in DCLB metabolism leading to toxicity. Reduction in the dose of clobazam to 0.3 mg/kg/day was associated with resolution of the non-epileptic neurological symptoms, reduction in DCLB plasma levels, and maintenance of seizure control.

    PMID:16780634 Aylett SE et al; Dev Med Child Neurol 48 (7): 612-5 (2006)

    Clobazam has known human metabolites that include 4-Hydroxyclobazam and N-desmethylclobazam.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    The mean elimination half life of an oral dose of clobazam 40 mg is 32 hours. It's main metabolite, norclobazam, as a half life of 57 hours. The half life in adult patients with epilepsy are higher than those that are healthy.

    The mean elimination half-life of clobazam is approximately 36-42 hours and the mean elimination half-life of N-desmethylclobazam is approximately 71-82 hours.

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2297

    5.8 Mechanism of Action

    Clobazam binds at distinct binding sites associated with the chloride ionopore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionopore is open. As a result, hyper polarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.

    API SUPPLIERS

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    01

    EUROAPI

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    ChemOutsourcing
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    • fda
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-27

    Pay. Date : 2013-02-13

    DMF Number : 18340

    Submission : 2005-05-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-314 - Rev 01

    Issue Date : 2022-02-08

    Type : Chemical

    Substance Number : 1974

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10337

    Registrant's Address : Brueningstrasse 50, 65926 Frankfurt am Main, Germany

    Initial Date of Registration : 2006-03-09

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 82348-103

    Start Marketing Date : 2020-07-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    EUROAPI Compnay Banner

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    02

    Honour Lab Limited

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ChemOutsourcing
    Booth #88
    • fda
    • EDQM
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-08-24

    Pay. Date : 2015-05-26

    DMF Number : 29351

    Submission : 2015-06-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-237 - Rev 00

    Issue Date : 2023-02-13

    Type : Chemical

    Substance Number : 1974

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 69037-0009

    Start Marketing Date : 2011-10-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF CN arrow-down
    ✖
    Available Reg Filing : CN
    AUDIT
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    03

    EUROAPI

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    ChemOutsourcing
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    • fda
    • EDQM
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-281 - Rev 00

    Issue Date : 2022-02-16

    Type : Chemical

    Substance Number : 1974

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    EUROAPI Compnay Banner

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    04

    F.I.S. Fabbrica Italiana Sintetici

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ACS Fall 2025
    Not Confirmed
    arrow

    F.I.S. Fabbrica Italiana Sintetici

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ACS Fall 2025
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-10-02

    Pay. Date : 2015-03-11

    DMF Number : 24728

    Submission : 2011-02-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48087-0094

    Start Marketing Date : 2010-11-24

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    05

    Raks Pharma

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ACS Fall 2025
    Not Confirmed
    arrow

    Raks Pharma

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ACS Fall 2025
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-07-08

    Pay. Date : 2016-05-20

    DMF Number : 30540

    Submission : 2016-05-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 47621-047

    Start Marketing Date : 2016-03-28

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    06

    MSN Laboratories

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ACS Fall 2025
    Not Confirmed
    arrow

    MSN Laboratories

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ACS Fall 2025
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-03-07

    Pay. Date : 2017-10-10

    DMF Number : 30875

    Submission : 2016-09-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-322 - Rev 00

    Issue Date : 2023-07-18

    Type : Chemical

    Substance Number : 1974

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-08-08

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0383

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 69766-016

    Start Marketing Date : 2016-08-25

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    Piramal Pharma Solutions

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ACS Fall 2025
    Not Confirmed
    arrow

    Piramal Pharma Solutions

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ACS Fall 2025
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-02

    Pay. Date : 2015-09-24

    DMF Number : 29164

    Submission : 2015-03-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-06-29

    Valid Till : 2025-02-07

    Written Confirmation Number : WC-0123

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65085-0054

    Start Marketing Date : 2018-12-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    08

    Micro Labs Limited

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ACS Fall 2025
    Not Confirmed
    arrow

    Micro Labs Limited

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ACS Fall 2025
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-01-04

    Pay. Date : 2017-12-02

    DMF Number : 32059

    Submission : 2017-11-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-168 - Rev 02

    Issue Date : 2024-10-14

    Type : Chemical

    Substance Number : 1974

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-08-11

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0225

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42571-308

    Start Marketing Date : 2022-01-19

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    09

    Cambrex Corporation

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ACS Fall 2025
    Not Confirmed
    arrow

    Cambrex Corporation

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ACS Fall 2025
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-07-05

    Pay. Date : 2015-09-24

    DMF Number : 29061

    Submission : 2015-01-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12828-0084

    Start Marketing Date : 2016-07-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    10

    Centaur Pharmaceuticals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ACS Fall 2025
    Not Confirmed
    arrow

    Centaur Pharmaceuticals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ACS Fall 2025
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-10-13

    Pay. Date : 2015-06-05

    DMF Number : 29407

    Submission : 2015-05-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2004-118 - Rev 04

    Issue Date : 2023-10-19

    Type : Chemical

    Substance Number : 1974

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0107

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 64330-110

    Start Marketing Date : 2015-02-23

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    Listed Suppliers

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    01

    EUROAPI

    France
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Clobazam

    About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...

    EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our CDMO activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.
    EUROAPI Compnay Banner

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    02

    Honour Lab Limited

    India
    arrow
    ChemOutsourcing
    Booth #88
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    Clobazam

    About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...

    Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standards, we are committed to delivering excellence with innovative, holistic solutions to clients across the globe by leveraging our expertise in chemistry. Operating through our two core verticals - Honour Synthesis and Honour Specialty, we embrace the science of partnership and possibilities. Our team of over 2,500 professionals collaborates closely with pharmaceutical, biotechnology, and specialty industries worldwide to develop practical, scalable solutions.
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    03

    Calyx Chemicals & Pharmaceuticals

    India
    ACS Fall 2025
    Not Confirmed
    arrow

    Calyx Chemicals & Pharmaceuticals

    India
    arrow
    ACS Fall 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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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    Clobazam

    About the Company : CALYX is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, with its manufacturing facility located in Tarapur, Maharashtra (India). The site has been su...

    CALYX is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, with its manufacturing facility located in Tarapur, Maharashtra (India). The site has been successfully inspected and approved by major regulatory authorities, including the USFDA, EDQM, WHO-Geneva, and other international agencies. The company has been a pioneer and industry leader in the manufacturing of APIs, particularly in the therapeutic areas of Anti-Tuberculosis, Anti-Malarial, and Macrolide segments, catering to the treatment of acute diseases.
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    04

    Cambrex Corporation

    U.S.A
    ACS Fall 2025
    Not Confirmed
    arrow

    Cambrex Corporation

    U.S.A
    arrow
    ACS Fall 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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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    Flag U.S.A
    Virtual Booth Virtual Booth
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    Clobazam

    About the Company : Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years...

    Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years of API development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets. We put all of our energy and experience into being your partner of choice. We create value for customers through manufacturing excellence, reliable quality and innovative science. Our people are the experts that our customers enjoy working with.
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    05

    Centaur Pharmaceuticals

    India
    ACS Fall 2025
    Not Confirmed
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    Centaur Pharmaceuticals

    India
    arrow
    ACS Fall 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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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    Clobazam

    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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    06

    DEAFARMA

    Italy
    ACS Fall 2025
    Not Confirmed
    arrow

    DEAFARMA

    Italy
    arrow
    ACS Fall 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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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    Virtual Booth Virtual Booth
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    Clobazam

    About the Company : In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territo...

    In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territory. DEAFARMA works with success in the pharmaceutical raw materials field through Agencies and professional relations with the most important European and Asiatic factories. Our partners are well known, reliable producers and all of them are operating in accordance with the latest GMP Rules. The APIs mentioned in the DEAFARMA catalogue are always supported by DMF and/or CEP.
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    07

    Lake Chemicals

    India
    ACS Fall 2025
    Not Confirmed
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    Lake Chemicals

    India
    arrow
    ACS Fall 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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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    Clobazam

    About the Company : Lake Chemicals is specialized in Benzodiazepine and CNS range of products such as Alprazolam, Bromazepam, Clobazam, Clonazepam, Midazolam Salts, Lorazepam, Olanzapine Form-1 etc. H...

    Lake Chemicals is specialized in Benzodiazepine and CNS range of products such as Alprazolam, Bromazepam, Clobazam, Clonazepam, Midazolam Salts, Lorazepam, Olanzapine Form-1 etc. Holding COS for Alprazolam, Clonazepam, Bromazepam, Loperamide & Lorazepam and expecting for CLOBAZAM. Facility is Audited and approved by Cofepris Mexico, MOH Iran and other end customers like Pfizer, Teva, Apotex, J&J, Abbott, Novartis, Actavis etc and also other top generic companies in the world. Holding the EU written confirmation for all the above said products to export to Europe and couple of DMF already registered with few of the MOH in Europe.
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    08

    Micro Labs Limited

    India
    ACS Fall 2025
    Not Confirmed
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    Micro Labs Limited

    India
    arrow
    ACS Fall 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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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    Clobazam

    About the Company : Micro Labs Limited is a diversified healthcare company with cutting-edge R&D, advanced manufacturing facilities, and a strong distribution network. It ranks among India's top pharm...

    Micro Labs Limited is a diversified healthcare company with cutting-edge R&D, advanced manufacturing facilities, and a strong distribution network. It ranks among India's top pharmaceutical companies, with a leading presence in cardiology, diabetology, anti-infectives, ophthalmology, and pain management. The company is known for its high-quality medicines, including the popular fever management brand, Dolo. Micro Labs continues to grow through innovation, research, and global expansion, delivering healthcare solutions that meet international standards.
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    09

    Piramal Pharma Solutions

    U.S.A
    ACS Fall 2025
    Not Confirmed
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    Piramal Pharma Solutions

    U.S.A
    arrow
    ACS Fall 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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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    Clobazam

    About the Company : Piramal Pharma Solutions (PPS) is a CDMO that provides end-to-end solutions for drug development and manufacturing across the drug life cycle to its clients in North America, Europ...

    Piramal Pharma Solutions (PPS) is a CDMO that provides end-to-end solutions for drug development and manufacturing across the drug life cycle to its clients in North America, Europe and Asia through a globally integrated network of facilities. It offers a range of services from drug discovery to commercial supply of APIs and finished dosage forms, along with specialized services like HPAPIs, antibody drug conjugations, sterile fill/finish, peptide products and services and potent solid oral drug products. PPS also provides services for biologics, including vaccines, gene therapies and monoclonal antibodies through its subsidiary Yapan Bio.
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    10

    Raks Pharma

    India
    ACS Fall 2025
    Not Confirmed
    arrow

    Raks Pharma

    India
    arrow
    ACS Fall 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Clobazam

    About the Company : Founded by a group of highly committed Technocrats in year 2009, today Raks Pharma is a partner of choice for pharmaceutical companies across the globe to source Active Pharmaceuti...

    Founded by a group of highly committed Technocrats in year 2009, today Raks Pharma is a partner of choice for pharmaceutical companies across the globe to source Active Pharmaceuticals Ingredients and their intermediates. Till date the company has invested around US $ 50M and has filed 23 US DMFs and 1 CEP with US and European Authority's respectively. The manufacturing facility is also approved by USFDA and WHO. We at Raks are dedicated to develop and manufacture active pharmaceutical ingredients and intermediates. We are committed to create value through intellectual property, quality systems and customer relation across the globe.
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P\/IMP-13345\/2024 DT: 03.12.2024.","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CAMBREX PROFARMACO MILANO S R L","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"9.75","actualQuantity":"9.75","unit":"KGS","unitRateFc":"2000","totalValueFC":"19725.1","currency":"USD","unitRateINR":"171900","date":"21-Dec-2024","totalValueINR":"1676025","totalValueInUsd":"19725.1","indian_port":"Hyderabad Air","hs_no":"29337200","bill_no":"7377769","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA EUGENIO CURIEL 34 20067 PAULLO MILANO SDNF Italy","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734719400,"product":"CLOBAZAM PH.EUR (FREE SAMPLE 1 GRAM) (CBN NOC NO. P\/IMP-13345\/2024 DT: 03.12.2024)CLOBAZAM PH.EUR (FREE SAMPLE 1 GRAM)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CAMBREX PROFARMACO MILANO S R L","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"10.25","actualQuantity":"10.25","unit":"KGS","unitRateFc":"2000","totalValueFC":"20736.7","currency":"USD","unitRateINR":"171900","date":"21-Dec-2024","totalValueINR":"1761975","totalValueInUsd":"20736.7","indian_port":"Hyderabad Air","hs_no":"29337200","bill_no":"7377769","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA EUGENIO CURIEL 34 20067 PAULLO MILANO SDNF Italy","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742236200,"product":"CLOBAZAM MACINATO ( IMP LIC NO :P-IMP-10005\/2025DT:02\/01\/2025) F.NO:ITA\/IMP\/DEC-2024\/000056)","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"CAMBREX PROFARMACO MILANO SRL","supplierCountry":"ITALY","foreign_port":"MILANO","customer":"APL HEALTHCARE LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"2000","totalValueFC":"101365.1","currency":"USD","unitRateINR":"175600","date":"18-Mar-2025","totalValueINR":"8780000","totalValueInUsd":"101365.1","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29337200","bill_no":"8946315","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILANO","supplierAddress":"VIA E CURIEL 34-20067 PAULIO MI ITALY SDNF Italy","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742236200,"product":"CLOBAZAM MICRO ( IMP LIC NO :P-IMP-10005\/2025DT:02\/01\/2025) F.NO:ITA\/IMP\/DEC-2024\/000056) (FREE OF CHARGE","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"CAMBREX PROFARMACO MILANO SRL","supplierCountry":"ITALY","foreign_port":"MILANO","customer":"APL HEALTHCARE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.001","unit":"KGS","unitRateFc":"3500","totalValueFC":"3.5","currency":"USD","unitRateINR":"307300","date":"18-Mar-2025","totalValueINR":"307.3","totalValueInUsd":"3.5","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29337200","bill_no":"8946315","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILANO","supplierAddress":"VIA E CURIEL 34-20067 PAULIO MI ITALY SDNF Italy","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746729000,"product":"CLOBAZAM","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO LABS LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"2454.7","totalValueFC":"61619.3","currency":"USD","unitRateINR":"210000","date":"09-May-2025","totalValueINR":"5250000","totalValueInUsd":"61619.3","indian_port":"Vizag-HIPL SEZ","hs_no":"29337200","bill_no":"9952690","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"HETERO INFRASTRUCTURE SEZ LTD N.NARASAPURAM VILLAGE,NAKKAPALLY MA SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751567400,"product":"CLOBAZAM (MACINATO) OR (CLOBAZAM PH EUR)(WITH FREE SAMPLE OF1 GRAM)(CAS NO.22316-47-8)CLOBAZAM (MACINATO) OR (CLOBAZAM PH EUR)(WITH FREE SAMPLE OF","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CAMBREX PROFARMACO MILANO SRL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"21.25","actualQuantity":"21.25","unit":"KGS","unitRateFc":"2000","totalValueFC":"42566.2","currency":"USD","unitRateINR":"172400","date":"04-Jul-2025","totalValueINR":"3663500","totalValueInUsd":"42566.2","indian_port":"Hyderabad Air","hs_no":"29337200","bill_no":"3051092","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA E. CURIEL, 34 - 20067 PAULLO MI #NAME? SDNF Italy","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751913000,"product":"CLOBAZAM MACINATO ( IMP LIC NO :P-IMP-10323\/2025DT:21\/05\/2025) F.NO:ITA\/IMP\/MAY-2025\/000022)","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"CAMBREX PROFARMACO MILANO SRL","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"APL HEALTHCARE LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"2000","totalValueFC":"100155.8","currency":"USD","unitRateINR":"172400","date":"08-Jul-2025","totalValueINR":"8620000","totalValueInUsd":"100155.8","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29337200","bill_no":"3126402","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"VIA E CURIEL PAULIO MI ITALY PAULIO MI ITALY SDNF Italy","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"}]
    10-Jan-2022
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    Drugs in Development

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Pharmanovia Acquires Global Central Nervous System (CNS) Portfolio from Sanofi

    Details:

    Pharmanovia expands its neurology portfolio with the acquisition of 11 central nervous system (CNS) brands from Sanofi, including Frisium (clobazam), Gardenal (phenobarbital), Tercian (cyamemazine), Stemetil, Sentil, Urbanyl, Urbanil, Urbanol, Urbadan, Noiafren and Castilium.


    Lead Product(s): Clobazam

    Therapeutic Area: Psychiatry/Psychology Brand Name: Frisium

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Pharmanovia

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Divestment September 18, 2023

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Clobazam

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Pharmanovia

    Deal Size : Undisclosed

    Deal Type : Divestment

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    Pharmanovia Acquires Global Central Nervous System (CNS) Portfolio from Sanofi

    Details : Pharmanovia expands its neurology portfolio with the acquisition of 11 central nervous system (CNS) brands from Sanofi, including Frisium (clobazam), Gardenal (phenobarbital), Tercian (cyamemazine), Stemetil, Sentil, Urbanyl, Urbanil, Urbanol, Urbadan, N...

    Product Name : Frisium

    Product Type : Controlled Substance

    Upfront Cash : Undisclosed

    September 18, 2023

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    Sanofi and Cipla Form Exclusive Distribution Partnership for CNS Portfolio in India

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    Cipla will distribute and promote Sanofi India's CNS product range, including Frisium (clobazam), an anti-epileptic medication, in India.


    Lead Product(s): Clobazam

    Therapeutic Area: Neurology Brand Name: Frisium

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Sanofi

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership March 27, 2024

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    Cipla

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    Lead Product(s) : Clobazam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Sanofi

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Sanofi and Cipla Form Exclusive Distribution Partnership for CNS Portfolio in India

    Details : Cipla will distribute and promote Sanofi India's CNS product range, including Frisium (clobazam), an anti-epileptic medication, in India.

    Product Name : Frisium

    Product Type : Controlled Substance

    Upfront Cash : Undisclosed

    March 27, 2024

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    Assertio Holdings, Inc. Announces FDA Orange Book Listing for New Sympazan® Oral Film Patent

    Details:

    Sympazan® (clobazam), oral film developed with PharmFilm® technology, is a prescription medicine used to treat seizures associated with Lennox-Gastaut Syndrome in people 2 years of age or older. Clobazam positive allosteric modulator of GABA receptor.


    Lead Product(s): Clobazam

    Therapeutic Area: Neurology Brand Name: Sympazan

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 01, 2023

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    Assertio Therapeutics

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    Lead Product(s) : Clobazam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Assertio Holdings, Inc. Announces FDA Orange Book Listing for New Sympazan® Oral Film Patent

    Details : Sympazan® (clobazam), oral film developed with PharmFilm® technology, is a prescription medicine used to treat seizures associated with Lennox-Gastaut Syndrome in people 2 years of age or older. Clobazam positive allosteric modulator of GABA receptor.

    Product Name : Sympazan

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    September 01, 2023

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    Assertio Announces Partnership with the Lennox-Gastaut Syndrome (LGS) Foundation

    Details:

    SYMPAZAN (clobazam) is the first and only FDA-approved oral film formulation of clobazam, a benzodiazepine approved for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.


    Lead Product(s): Clobazam

    Therapeutic Area: Neurology Brand Name: Sympazan

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: LGS Foundation

    Deal Size: $0.1 million Upfront Cash: Undisclosed

    Deal Type: Partnership January 17, 2023

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    Assertio Therapeutics

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    Lead Product(s) : Clobazam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : LGS Foundation

    Deal Size : $0.1 million

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Assertio Announces Partnership with the Lennox-Gastaut Syndrome (LGS) Foundation

    Details : SYMPAZAN (clobazam) is the first and only FDA-approved oral film formulation of clobazam, a benzodiazepine approved for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

    Product Name : Sympazan

    Product Type : Controlled Substance

    Upfront Cash : Undisclosed

    January 17, 2023

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    Aquestive Therapeutics Licenses Sympazan® (clobazam) Oral Film to Assertio Holdings, Inc.

    Details:

    Under the terms of the definitive agreement, Aquestive exclusively licensed the product’s intellectual property to Assertio for an upfront payment. Aquestive also entered into a long-term supply agreement with Assertio for Sympazan (clobazam) oral film.


    Lead Product(s): Clobazam

    Therapeutic Area: Neurology Brand Name: Sympazan

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Assertio Therapeutics

    Deal Size: Undisclosed Upfront Cash: $9.0 million

    Deal Type: Licensing Agreement October 27, 2022

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    Aquestive Therapeutics

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    Lead Product(s) : Clobazam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Assertio Therapeutics

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Aquestive Therapeutics Licenses Sympazan® (clobazam) Oral Film to Assertio Holdings, Inc.

    Details : Under the terms of the definitive agreement, Aquestive exclusively licensed the product’s intellectual property to Assertio for an upfront payment. Aquestive also entered into a long-term supply agreement with Assertio for Sympazan (clobazam) oral film...

    Product Name : Sympazan

    Product Type : Controlled Substance

    Upfront Cash : $9.0 million

    October 27, 2022

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    FDA Orange Book

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    ALKEM LABS LTD

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    ACS Fall 2025
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    ALKEM LABS LTD

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    RLD : No

    TE Code : AB

    CLOBAZAM

    Brand Name : CLOBAZAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 20MG

    Approval Date : 2019-09-06

    Application Number : 212714

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    ALKEM LABS LTD

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    ALKEM LABS LTD

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    RLD : No

    TE Code :

    CLOBAZAM

    Brand Name : CLOBAZAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Approval Date : 2020-12-21

    Application Number : 212714

    RX/OTC/DISCN : RX

    RLD : No

    TE Code :

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    APOTEX

    Canada
    ACS Fall 2025
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    RLD : No

    TE Code :

    CLOBAZAM

    Brand Name : CLOBAZAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 10MG

    Approval Date : 2020-06-09

    Application Number : 209853

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    APOTEX

    Canada
    ACS Fall 2025
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    RLD : No

    TE Code :

    CLOBAZAM

    Brand Name : CLOBAZAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 20MG

    Approval Date : 2020-06-09

    Application Number : 209853

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    BIONPHARMA

    U.S.A
    ACS Fall 2025
    Not Confirmed
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    BIONPHARMA

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    RLD : No

    TE Code : AB

    CLOBAZAM

    Brand Name : CLOBAZAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 10MG

    Approval Date : 2018-10-22

    Application Number : 208825

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    MICRO LABS

    India
    ACS Fall 2025
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    Not Confirmed
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    RLD : No

    TE Code : AB

    CLOBAZAM

    Brand Name : CLOBAZAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 10MG

    Approval Date : 2019-01-30

    Application Number : 211711

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    MICRO LABS

    India
    ACS Fall 2025
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    RLD : No

    TE Code : AB

    CLOBAZAM

    Brand Name : CLOBAZAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 20MG

    Approval Date : 2019-01-30

    Application Number : 211711

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    UPSHER SMITH LABS

    U.S.A
    ACS Fall 2025
    Not Confirmed
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    UPSHER SMITH LABS

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    RLD : No

    TE Code : AB

    CLOBAZAM

    Brand Name : CLOBAZAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 10MG

    Approval Date : 2018-10-22

    Application Number : 209687

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    UPSHER SMITH LABS

    U.S.A
    ACS Fall 2025
    Not Confirmed
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    RLD : No

    TE Code : AB

    CLOBAZAM

    Brand Name : CLOBAZAM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 20MG

    Approval Date : 2018-10-22

    Application Number : 209687

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    OTTER PHARMS

    Country
    ACS Fall 2025
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    RLD : Yes

    TE Code :

    CLOBAZAM

    Brand Name : SYMPAZAN

    Dosage Form : FILM;ORAL

    Dosage Strength : 5MG

    Approval Date : 2018-11-01

    Application Number : 210833

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    SANOFI-AVENTIS SpA

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info :

    Registration Country : Italy

    Clobazam

    Brand Name : Frisium

    Dosage Form : Capsule

    Dosage Strength : 30 Cps 10 Mg  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Sanofi-Aventis (Switzerland) SA

    France
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    Registration Country : Switzerland

    Clobazam

    Brand Name : Urbanyl

    Dosage Form : Tabl

    Dosage Strength : 10mg

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Rochem International Inc

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    Booth #12.0F117
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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

    Brand Name : Maltitol

    Application : Coating Systems & Additives, Fillers, Diluents & Binders, Taste Masking, Thickeners and Stabilizers

    Excipient Details : Maltitol is widely used as a coating agent, diluent, sweetener and bulking agent in various dosage forms such as tablets, capsules, granules & syrups.

    Pharmacopoeia Ref : NA

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    Ingredient(s) : Maltitol Excipient

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    DKSH

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    Booth #8.0P66
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    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Brand Name : XANTURAL® 11000

    Application : Rheology Modifiers, Thickeners and Stabilizers, Topical

    Excipient Details : Xantural 11000 is used as a stabilizer and rheology modifier in oral dosage forms such as syrups, suspensions & solutions & in topical formulations.

    Pharmacopoeia Ref : JP, EP, USP/NF

    Technical Specs : N/A

    Ingredient(s) : Xanthan Gum

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    Pharm-RX Chemical

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    Virtual BoothPharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

    Brand Name : Xanthan Gum

    Application : API Stability Enhancers, Thickeners and Stabilizers

    Excipient Details : Xanthan gum is widely used in oral dosage forms as a suspending and thickening agent. It is also used in topical formulations as a stabilizer.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

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    Nanjing Well Pharmaceutical

    China
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    ACS Fall 2025
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    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

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    DKSH

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    Booth #8.0P66
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    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Brand Name : XANTURAL® 180

    Application : Rheology Modifiers, Thickeners and Stabilizers, Topical

    Excipient Details : Xantural 180 is used as a rheology modifier & stabilizer in oral dosage forms such as solutions, suspensions, and syrups & in topical formulations.

    Pharmacopoeia Ref : JP, EP, USP/NF

    Technical Specs : N/A

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    Rochem International Inc

    U.S.A
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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

    Brand Name : Xanthan Gum

    Application : API Stability Enhancers, Thickeners and Stabilizers

    Excipient Details : Xanthan gum, a polysaccharide widely used in many industries as a food additive, thickening agent and stabilizer in topical formulations.

    Pharmacopoeia Ref : NA

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    Nanjing Well Pharmaceutical

    China
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    ACS Fall 2025
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Brand Name : Propylene Glycol

    Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical

    Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.

    Pharmacopoeia Ref : ChP/USP/EP/JP

    Technical Specs : NA

    Ingredient(s) : Propylene Glycol

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    Gangwal Chemicals

    India
    ACS Fall 2025
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    Rochem International Inc

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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

    Brand Name : Xanthan Gum

    Application : API Stability Enhancers, Thickeners and Stabilizers

    Excipient Details : Xanthan gum, a polysaccharide widely used in many industries as a food additive, thickening agent and stabilizer in topical formulations.

    Pharmacopoeia Ref : NA

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    Brand Name : Xanthan Gum

    Application : API Stability Enhancers, Thickeners and Stabilizers

    Excipient Details : Xanthan gum is widely used in oral dosage forms as a suspending and thickening agent. It is also used in topical formulations as a stabilizer.

    Pharmacopoeia Ref : NA

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    01

    Brand Name : Onfi

    Clobazam

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    ACS Fall 2025
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    Brand Name : Onfi

    Denmark
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    ACS Fall 2025
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    Lundbeck

    Clobazam

    Main Therapeutic Indication : CNS & Anesthesia

    Currency : USD

    2020 Revenue in Millions : 104

    2019 Revenue in Millions : 171

    Growth (%) : -39

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    Denmark
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    Lundbeck

    Clobazam

    Main Therapeutic Indication : Neurology

    Currency : USD

    2021 Revenue in Millions : 77

    2020 Revenue in Millions : 103

    Growth (%) : -21

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    Brand Name : Onfi

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    Brand Name : Onfi

    Denmark
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    ACS Fall 2025
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    Lundbeck

    Clobazam

    Main Therapeutic Indication : Neurology

    Currency : USD

    2022 Revenue in Millions : 61

    2021 Revenue in Millions : 77

    Growth (%) : -20

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    Clobazam

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    Brand Name : Onfi

    Denmark
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    ACS Fall 2025
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    Lundbeck

    Clobazam

    Main Therapeutic Indication : Neuroscience and Mental Health

    Currency : USD

    2015 Revenue in Millions : 138

    2014 Revenue in Millions : 264

    Growth (%) : 91%

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    Denmark
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    Lundbeck

    Clobazam

    Main Therapeutic Indication : Neuroscience/Mental Health

    Currency : USD

    2014 Revenue in Millions : 61%

    2013 Revenue in Millions :

    Growth (%) :

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    Denmark
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    Lundbeck

    Clobazam

    Main Therapeutic Indication : Neurological/Mental Disorders

    Currency : USD

    2017 Revenue in Millions : 514

    2016 Revenue in Millions : 410

    Growth (%) : 25

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    Brand Name : Onfi

    Denmark
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    Lundbeck

    Clobazam

    Main Therapeutic Indication : Neurological/Mental Disorders

    Currency : USD

    2018 Revenue in Millions : 475

    2017 Revenue in Millions : 453

    Growth (%) : 5%

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    Brand Name : Onfi

    Denmark
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    Lundbeck

    Clobazam

    Main Therapeutic Indication : CNS & Anesthesia

    Currency : USD

    2019 Revenue in Millions : 158

    2018 Revenue in Millions : 475

    Growth (%) : -67

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    ABOUT THIS PAGE

    Looking for 22316-47-8 / Clobazam API manufacturers, exporters & distributors?

    Clobazam manufacturers, exporters & distributors 1

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

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

    PharmaCompass also assists you with knowing the Clobazam API Price utilized in the formulation of products. Clobazam API Price is not always fixed or binding as the Clobazam Price is obtained through a variety of data sources. The Clobazam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Clobazam

    Synonyms

    Frisium, Urbanyl, Chlorepin, Clorepin, Urbadan, 22316-47-8

    Cas Number

    22316-47-8

    Unique Ingredient Identifier (UNII)

    2MRO291B4U

    About Clobazam

    A benzodiazepine derivative that is a long-acting GABA-A RECEPTOR agonist. It is used as an antiepileptic in the treatment of SEIZURES, including seizures associated with LENNOX-GASTAUT SYNDROME. It is also used as an anxiolytic, for the short-term treatment of acute ANXIETY.

    Clobazam [USAN:BAN:INN] Manufacturers

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

    Clobazam [USAN:BAN:INN] Suppliers

    A Clobazam [USAN:BAN:INN] supplier is an individual or a company that provides Clobazam [USAN:BAN:INN] active pharmaceutical ingredient (API) or Clobazam [USAN:BAN:INN] finished formulations upon request. The Clobazam [USAN:BAN:INN] suppliers may include Clobazam [USAN:BAN:INN] API manufacturers, exporters, distributors and traders.

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    Clobazam [USAN:BAN:INN] USDMF

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

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

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    Clobazam [USAN:BAN:INN] 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 Clobazam [USAN:BAN:INN] Drug Master File in Japan (Clobazam [USAN:BAN:INN] JDMF) empowers Clobazam [USAN:BAN:INN] 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 Clobazam [USAN:BAN:INN] JDMF during the approval evaluation for pharmaceutical products. At the time of Clobazam [USAN:BAN:INN] JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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    Clobazam [USAN:BAN:INN] CEP

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

    A Clobazam [USAN:BAN:INN] CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clobazam [USAN:BAN:INN] 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 Clobazam [USAN:BAN:INN] suppliers with CEP (COS) on PharmaCompass.

    Clobazam [USAN:BAN:INN] WC

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

    click here to find a list of Clobazam [USAN:BAN:INN] suppliers with Written Confirmation (WC) on PharmaCompass.

    Clobazam [USAN:BAN:INN] 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 Clobazam [USAN:BAN:INN] as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Clobazam [USAN:BAN:INN] 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 Clobazam [USAN:BAN:INN] 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 Clobazam [USAN:BAN:INN] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clobazam [USAN:BAN:INN] NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Clobazam [USAN:BAN:INN] suppliers with NDC on PharmaCompass.

    Clobazam [USAN:BAN:INN] GMP

    Clobazam [USAN:BAN:INN] 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 Clobazam [USAN:BAN:INN] 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 Clobazam [USAN:BAN:INN] GMP manufacturer or Clobazam [USAN:BAN:INN] GMP API supplier for your needs.

    Clobazam [USAN:BAN:INN] CoA

    A Clobazam [USAN:BAN:INN] CoA (Certificate of Analysis) is a formal document that attests to Clobazam [USAN:BAN:INN]'s compliance with Clobazam [USAN:BAN:INN] specifications and serves as a tool for batch-level quality control.

    Clobazam [USAN:BAN:INN] CoA mostly includes findings from lab analyses of a specific batch. For each Clobazam [USAN:BAN:INN] 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.

    Clobazam [USAN:BAN:INN] may be tested according to a variety of international standards, such as European Pharmacopoeia (Clobazam [USAN:BAN:INN] EP), Clobazam [USAN:BAN:INN] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clobazam [USAN:BAN:INN] 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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