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    Also known as: Terbutaline solution, Terbutaline (sulfate), Mls000069693, Smr000058516, Kwd-2019, Sr-01000000174
    Molecular Formula
    C12H21NO7S
    Molecular Weight
    323.36  g/mol
    InChI Key
    MUPQZWGSBCWCAV-UHFFFAOYSA-N
    Terbutaline Sulfate
    A selective beta-2 adrenergic agonist used as a bronchodilator and tocolytic.
    1 2D Structure

    Terbutaline Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-[2-(tert-butylamino)-1-hydroxyethyl]benzene-1,3-diol;sulfuric acid
    2.1.2 InChI
    InChI=1S/C12H19NO3.H2O4S/c1-12(2,3)13-7-11(16)8-4-9(14)6-10(15)5-8;1-5(2,3)4/h4-6,11,13-16H,7H2,1-3H3;(H2,1,2,3,4)
    2.1.3 InChI Key
    MUPQZWGSBCWCAV-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C)(C)NCC(C1=CC(=CC(=C1)O)O)O.OS(=O)(=O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Arubendol

    2. Asthmoprotect

    3. Brethaire

    4. Brethine

    5. Bricanyl

    6. Bricanyl Sa

    7. Butaliret

    8. Butalitab

    9. Contimit

    10. Kwd 2019

    11. Kwd-2019

    12. Kwd2019

    13. Monovent

    14. Taziken

    15. Tedipulmo

    16. Terbasmin

    17. Terbul

    18. Terbutalin Al

    19. Terbutalin Ratiopharm

    20. Terbutalin Stada

    21. Terbutalin Von Ct

    22. Terbutalin-ratiopharm

    23. Terbutaline

    24. Terbutaline Sulfate

    25. Terbuturmant

    2.2.2 Depositor-Supplied Synonyms

    1. Terbutaline Solution

    2. Terbutaline (sulfate)

    3. Mls000069693

    4. Smr000058516

    5. Kwd-2019

    6. Sr-01000000174

    7. Opera_id_498

    8. Schembl41870

    9. Mls001148384

    10. Spectrum1500558

    11. Chembl1160544

    12. Regid_for_cid_657301

    13. Hms500d20

    14. Hms1921c15

    15. Hms2092k19

    16. Hms2231h10

    17. Hms3259j05

    18. Hms3372i16

    19. Pharmakon1600-01500558

    20. Ccg-39265

    21. Nsc757336

    22. Akos015960700

    23. Nc00619

    24. Ncgc00094789-01

    25. Ncgc00094789-02

    26. Ncgc00094789-03

    27. Ncgc00094789-04

    28. Ac-12158

    29. Ac-33172

    30. Vu0244552-7

    31. Sr-01000000174-4

    32. 5-[2-(tert-butylamino)-1-hydroxyethyl]benzene-1,3-diol,sulfuric Acid

    2.3 Create Date
    2005-06-29
    3 Chemical and Physical Properties
    Molecular Weight 323.36 g/mol
    Molecular Formula C12H21NO7S
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count4
    Exact Mass323.10387318 g/mol
    Monoisotopic Mass323.10387318 g/mol
    Topological Polar Surface Area156 Ų
    Heavy Atom Count21
    Formal Charge0
    Complexity286
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameTerbutaline sulfate
    Drug LabelTerbutaline Sulfate, USP, the active ingredient of Terbutaline Sulfate Injection, USP, is a betaadrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. Each milliliter of...
    Active IngredientTerbutaline sulfate
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength2.5mg; 1mg/ml; 5mg
    Market StatusPrescription
    CompanyBedford; Hikma Farmaceutica; United Biomedcl; Fresenius Kabi Usa; Lannett; Impax Labs; Akorn

    2 of 2  
    Drug NameTerbutaline sulfate
    Drug LabelTerbutaline Sulfate, USP, the active ingredient of Terbutaline Sulfate Injection, USP, is a betaadrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. Each milliliter of...
    Active IngredientTerbutaline sulfate
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength2.5mg; 1mg/ml; 5mg
    Market StatusPrescription
    CompanyBedford; Hikma Farmaceutica; United Biomedcl; Fresenius Kabi Usa; Lannett; Impax Labs; Akorn

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Adrenergic beta-2 Receptor Agonists

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

    Bronchodilator Agents

    Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)

    Sympathomimetics

    Drugs that mimic the effects of stimulating postganglionic adrenergic sympathetic nerves. Included here are drugs that directly stimulate adrenergic receptors and drugs that act indirectly by provoking the release of adrenergic transmitters. (See all compounds classified as Sympathomimetics.)

    Tocolytic Agents

    Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete. (See all compounds classified as Tocolytic Agents.)

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TAMIL NADU.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713378600,"product":"TERBUTALINE SULFATE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"CAMBREX CORPORATION","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"20000","totalValueFC":"40403.7","currency":"USD","unitRateINR":"1687000","date":"18-Apr-2024","totalValueINR":"3374000","totalValueInUsd":"40403.7","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29225090","bill_no":"1001416","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]
    19-May-2021
    30-Jul-2024
    KGS
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    ABOUT THIS PAGE

    Terbutaline Sulfate Manufacturers

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

    Terbutaline Sulfate Suppliers

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

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

    Terbutaline Sulfate USDMF

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

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

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

    Terbutaline Sulfate CEP

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

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

    Terbutaline Sulfate 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 Terbutaline Sulfate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Terbutaline Sulfate GMP

    Terbutaline Sulfate 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 Terbutaline Sulfate 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 Terbutaline Sulfate GMP manufacturer or Terbutaline Sulfate GMP API supplier for your needs.

    Terbutaline Sulfate CoA

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

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

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