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    Chemistry

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    Also known as: Tizanidine hcl, 64461-82-1, Zanaflex, Tizanidine (hydrochloride), 5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine hydrochloride, Ds 103-282
    Molecular Formula
    C9H9Cl2N5S
    Molecular Weight
    290.17  g/mol
    InChI Key
    ZWUKMNZJRDGCTQ-UHFFFAOYSA-N
    FDA UNII
    B53E3NMY5C
    Tizanidine HCl
    Tizanidine Hydrochloride is the hydrochloride salt form of tizanidine, an imidazoline derivative structurally similar to clonidine and an adrenergic agonist with muscle relaxant property. Tizanidine stimulates alpha-2 adrenergic receptors in the central nervous system, thereby inhibiting presynaptic release of norepinephrine and increasing the inhibitory effect on alpha motor neurons and motor reflexes. Tizanidine exerts some activity at the postsynaptic excitatory amino acid receptors and imidazoline receptors which may contribute to the overall reduction in facilitation of spinal motor neurons. Overall, tizanidine hydrochloride causes muscle relaxation, reduces spasticity and antinociceptive effects.
    1 2D Structure

    Tizanidine HCl

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine;hydrochloride
    2.1.2 InChI
    InChI=1S/C9H8ClN5S.ClH/c10-5-1-2-6-8(15-16-14-6)7(5)13-9-11-3-4-12-9;/h1-2H,3-4H2,(H2,11,12,13);1H
    2.1.3 InChI Key
    ZWUKMNZJRDGCTQ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CN=C(N1)NC2=C(C=CC3=NSN=C32)Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    B53E3NMY5C
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 5-chloro-4-(2-imidazolin-2-yl-amino)-2,1,3-benzothiadiazole

    2. Ds 103-282

    3. Sirdalud

    4. Tizanidine

    5. Tizanidine Monohydrochloride

    6. Zanaflex

    2.3.2 Depositor-Supplied Synonyms

    1. Tizanidine Hcl

    2. 64461-82-1

    3. Zanaflex

    4. Tizanidine (hydrochloride)

    5. 5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine Hydrochloride

    6. Ds 103-282

    7. An021

    8. 5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)benzo[c][1,2,5]thiadiazol-4-amine Hydrochloride

    9. B53e3nmy5c

    10. Tizanidine (as Hydrochloride)

    11. 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole Monohydrochloride

    12. 5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine;hydrochloride

    13. Ds-103-282

    14. 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole Hydrochloride

    15. An-021

    16. 64461-82-1 (hcl)

    17. 2,1,3-benzothiadiazol-4-amine, 5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-, Monohydrochloride

    18. 5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-2,1,3-benzothiadiazole-4-amine Hydrochloride

    19. Smr000499584

    20. Unii-b53e3nmy5c

    21. Sr-01000765392

    22. Tizanidine * Hcl

    23. Zanaflex (tn)

    24. Mfcd00798231

    25. Tizanidine Hydrochloride [usan:usp:jan]

    26. 5-iodoisoquinolin-8-ol

    27. Schembl41199

    28. Mls001076686

    29. Mls001306412

    30. Mls001333593

    31. Chebi:9609

    32. Tizanidine Hydrochloride- Bio-x

    33. Chembl1200329

    34. Dtxsid9046990

    35. Ds-103282 Ch

    36. Hy-b0194a

    37. An-021a

    38. Nvd-422

    39. Amy18121

    40. Bcp28540

    41. Tox21_501114

    42. S1437

    43. Tizanidine Hydrochloride [mi]

    44. Tizanidine Hydrochloride (jp17/usp)

    45. Tizanidine Hydrochloride [jan]

    46. Akos005267234

    47. Brn0618691

    48. Ccg-220602

    49. Ccg-222418

    50. Ks-1120

    51. Lp01114

    52. Nc00654

    53. Tizanidine Hydrochloride [usan]

    54. Tizanidine Hydrochloride [mart.]

    55. Tizanidine Hydrochloride [vandf]

    56. Ncgc00261799-01

    57. Tizanidine Hydrochloride [who-dd]

    58. Ac-22546

    59. Bt164478

    60. Db-011661

    61. Ds-103282

    62. Ds103-282

    63. Ft-0656022

    64. Sw199068-2

    65. T2527

    66. En300-49853

    67. Tizanidine Hydrochloride [orange Book]

    68. D00776

    69. D70434

    70. Tizanidine Hydrochloride [ep Monograph]

    71. Tizanidine Hydrochloride [usp Impurity]

    72. Tizanidine Hydrochloride [usp Monograph]

    73. Tizanidine Hydrochloride, >=98% (hplc), Powder

    74. Sr-01000765392-4

    75. Q27274381

    76. Tizanidine Hydrochloride 100 Microg/ml In Acetonitrile

    77. 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazolehydrochloride

    78. Tizanidine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    79. (5-chloro-2,1,3-benzothiadiazol-4-yl)-(4,5-dihydro-1h-imidazol-2-yl)azanium;chloride

    80. 5-(chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine Hydrochloride

    81. 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole Monohydrochloride.

    82. 5-chloro-4-[(4,5-dihydro-1h-imidazol-2-yl)amino]-2,1,3-benzothiadiazole Hydrochloride

    83. 5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-2,1,3benzothiadiazole-4-amine Hydrochloride

    84. 5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)benzo[c][1,2,5]thiadiazol-4-aminehydrochloride

    85. Tizanidine Hydrochloride, 500 Mug/ml In Methanol, Certified Reference Material

    86. Tizanidine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 290.17 g/mol
    Molecular Formula C9H9Cl2N5S
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count2
    Exact Mass288.9955719 g/mol
    Monoisotopic Mass288.9955719 g/mol
    Topological Polar Surface Area90.4 Ų
    Heavy Atom Count17
    Formal Charge0
    Complexity300
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameTizanidine hydrochloride
    PubMed HealthTizanidine (By mouth)
    Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
    Drug LabelZanaflex (tizanidine hydrochloride) is a centrally acting 2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in...
    Active IngredientTizanidine hydrochloride
    Dosage FormTablet; Capsule
    RouteOral
    Strengtheq 4mg base; eq 2mg base; eq 6mg base
    Market StatusPrescription
    CompanyCorepharma; Mylan Pharms; Teva; Apotex; Sun Pharm Inds; Prosam Labs; Sandoz; Dr Reddys Labs; Mylan; Unichem Labs

    2 of 4  
    Drug NameZanaflex
    Drug LabelZanaflex (tizanidine hydrochloride) is a centrally acting 2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in...
    Active IngredientTizanidine hydrochloride
    Dosage FormTablet; Capsule
    RouteOral
    Strengtheq 4mg base; eq 2mg base; eq 6mg base
    Market StatusPrescription
    CompanyAcorda

    3 of 4  
    Drug NameTizanidine hydrochloride
    PubMed HealthTizanidine (By mouth)
    Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
    Drug LabelZanaflex (tizanidine hydrochloride) is a centrally acting 2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in...
    Active IngredientTizanidine hydrochloride
    Dosage FormTablet; Capsule
    RouteOral
    Strengtheq 4mg base; eq 2mg base; eq 6mg base
    Market StatusPrescription
    CompanyCorepharma; Mylan Pharms; Teva; Apotex; Sun Pharm Inds; Prosam Labs; Sandoz; Dr Reddys Labs; Mylan; Unichem Labs

    4 of 4  
    Drug NameZanaflex
    Drug LabelZanaflex (tizanidine hydrochloride) is a centrally acting 2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in...
    Active IngredientTizanidine hydrochloride
    Dosage FormTablet; Capsule
    RouteOral
    Strengtheq 4mg base; eq 2mg base; eq 6mg base
    Market StatusPrescription
    CompanyAcorda

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Muscle Relaxants, Central

    A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)

    Parasympatholytics

    Agents that inhibit the actions of the parasympathetic nervous system. The major group of drugs used therapeutically for this purpose is the MUSCARINIC ANTAGONISTS. (See all compounds classified as Parasympatholytics.)

    Analgesics

    Compounds capable of relieving pain without the loss of CONSCIOUSNESS. (See all compounds classified as Analgesics.)

    Anticonvulsants

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

    Adrenergic alpha-2 Receptor Agonists

    Compounds that bind to and activate ADRENERGIC ALPHA-2 RECEPTORS. (See all compounds classified as Adrenergic alpha-2 Receptor Agonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Central alpha-2 Adrenergic Agonist [EPC]; Adrenergic alpha2-Agonists [MoA]

    API Reference Price

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LTD","supplierCountry":"INDIA","foreign_port":"NA","customer":"SHRI VINAYAK CHEMEX (INDIA) PVT.LTD.","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"485","totalValueFC":"10350.9","currency":"USD","unitRateINR":"42648.9","date":"20-Dec-2022","totalValueINR":"852977.51","totalValueInUsd":"10350.9","indian_port":"JNPT","hs_no":"29342000","bill_no":"3817317","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"OFF NO 8 ARIHANT ENCLAVE ASHOK,CHA KRAVARTI RD KANDIVALI EAST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701369000,"product":"TIZANIDINE HYDROCHLORIDE USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"FARMAK, A.S","supplierCountry":"CZECH REPUBLIC","foreign_port":"PRAGUE - RUZYNE","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"7.34","actualQuantity":"7.344","unit":"KGS","unitRateFc":"2100","totalValueFC":"15581.1","currency":"USD","unitRateINR":"176610","date":"01-Dec-2023","totalValueINR":"1297023.84","totalValueInUsd":"15581.1","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"9029236","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE - RUZYNE","supplierAddress":"NA VICINCI 16\/3KLASTERNI HRADISKO OLOMOUCSDNF CZ","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735929000,"product":"TIZANIDINE HYDROCHLORIDE USP TIZANIDINE HYDROCHLORIDE USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"FARMAK, A.S","supplierCountry":"CZECH REPUBLIC","foreign_port":"PRAGUE - RUZYNE","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"4.58","actualQuantity":"4.58","unit":"KGS","unitRateFc":"1850","totalValueFC":"8509.4","currency":"USD","unitRateINR":"160210","date":"04-Jan-2025","totalValueINR":"733761.8","totalValueInUsd":"8509.4","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"7618628","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE - RUZYNE","supplierAddress":"NA VLCINCI 16\/3KLASTERNI HRADISKO77 9 00 OLOMOUC SDNF CZECH REPUBLIC","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742841000,"product":"TIZANIDINE HYDROCHLORIDE USP TIZANIDINE HYDROCHLORIDE","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"FARMAK, A.S","supplierCountry":"CZECH REPUBLIC","foreign_port":"PRAGUE - RUZYNE","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"10.71","actualQuantity":"10.71","unit":"KGS","unitRateFc":"1970","totalValueFC":"21264.9","currency":"USD","unitRateINR":"171981","date":"25-Mar-2025","totalValueINR":"1841916.51","totalValueInUsd":"21264.9","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"9085008","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE - RUZYNE","supplierAddress":"NA VICINCIKLASTERNI HRADISKO77900 O LOMOUC SDNF CZECH REPUBLIC","customerAddress":"ALEMBIC ROAD"}]
    04-Jan-2021
    25-Mar-2025
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    DOSAGE - TABLET;ORAL - EQ 2MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20397

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    DOSAGE - TABLET;ORAL - EQ 4MG BASE

    USFDA APPLICATION NUMBER - 20397

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    DOSAGE - CAPSULE;ORAL - EQ 2MG BASE

    USFDA APPLICATION NUMBER - 21447

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    DOSAGE - CAPSULE;ORAL - EQ 4MG BASE

    USFDA APPLICATION NUMBER - 21447

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    DOSAGE - CAPSULE;ORAL - EQ 6MG BASE

    USFDA APPLICATION NUMBER - 21447

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    ABOUT THIS PAGE

    Looking for 64461-82-1 / Tizanidine HCl API manufacturers, exporters & distributors?

    Tizanidine HCl manufacturers, exporters & distributors 1

    68

    PharmaCompass offers a list of Tizanidine HCl 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 Tizanidine HCl manufacturer or Tizanidine HCl supplier for your needs.

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

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

    API | Excipient name

    Tizanidine HCl

    Synonyms

    64461-82-1, Zanaflex, Tizanidine (hydrochloride), 5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine hydrochloride, Ds 103-282, An021

    Cas Number

    64461-82-1

    Unique Ingredient Identifier (UNII)

    B53E3NMY5C

    About Tizanidine HCl

    Tizanidine Hydrochloride is the hydrochloride salt form of tizanidine, an imidazoline derivative structurally similar to clonidine and an adrenergic agonist with muscle relaxant property. Tizanidine stimulates alpha-2 adrenergic receptors in the central nervous system, thereby inhibiting presynaptic release of norepinephrine and increasing the inhibitory effect on alpha motor neurons and motor reflexes. Tizanidine exerts some activity at the postsynaptic excitatory amino acid receptors and imidazoline receptors which may contribute to the overall reduction in facilitation of spinal motor neurons. Overall, tizanidine hydrochloride causes muscle relaxation, reduces spasticity and antinociceptive effects.

    Tizanidin Manufacturers

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

    Tizanidin Suppliers

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

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

    Tizanidin USDMF

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

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

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

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

    click here to find a list of Tizanidin suppliers with JDMF on PharmaCompass.

    Tizanidin KDMF

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

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

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

    click here to find a list of Tizanidin suppliers with KDMF on PharmaCompass.

    Tizanidin CEP

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

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

    Tizanidin WC

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

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

    Tizanidin 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 Tizanidin as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Tizanidin GMP

    Tizanidin 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 Tizanidin 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 Tizanidin GMP manufacturer or Tizanidin GMP API supplier for your needs.

    Tizanidin CoA

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

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

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