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Chemistry

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Also known as: Butorphanol tartrate, 58786-99-5, Butorphanol (+)-tartrate salt, Stadol (tn), Butorphanol tartrate salt, Butorphanol tartrate (jan/usp)
Molecular Formula
C25H35NO8
Molecular Weight
477.5  g/mol
InChI Key
GMTYREVWZXJPLF-BTVKVFNOSA-N

Butorphanol Tartrate
A synthetic morphinan analgesic with narcotic antagonist action. It is used in the management of severe pain.
1 2D Structure

Butorphanol Tartrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1S,9R,10S)-17-(cyclobutylmethyl)-17-azatetracyclo[7.5.3.01,10.02,7]heptadeca-2(7),3,5-triene-4,10-diol;(2R,3R)-2,3-dihydroxybutanedioic acid
2.1.2 InChI
InChI=1S/C21H29NO2.C4H6O6/c23-17-7-6-16-12-19-21(24)9-2-1-8-20(21,18(16)13-17)10-11-22(19)14-15-4-3-5-15;5-1(3(7)8)2(6)4(9)10/h6-7,13,15,19,23-24H,1-5,8-12,14H2;1-2,5-6H,(H,7,8)(H,9,10)/t19-,20+,21-;1-,2-/m11/s1
2.1.3 InChI Key
GMTYREVWZXJPLF-BTVKVFNOSA-N
2.1.4 Canonical SMILES
C1CCC2(C3CC4=C(C2(C1)CCN3CC5CCC5)C=C(C=C4)O)O.C(C(C(=O)O)O)(C(=O)O)O
2.1.5 Isomeric SMILES
C1CC[C@]2([C@H]3CC4=C([C@]2(C1)CCN3CC5CCC5)C=C(C=C4)O)O.[C@@H]([C@H](C(=O)O)O)(C(=O)O)O
2.2 Synonyms
2.2.1 MeSH Synonyms

1. 17-(cyclobutylmethyl)morphinan-3,14-diol

2. Apo-butorphanol

3. Bc 2627

4. Bc-2627

5. Bc2627

6. Beforal

7. Butorphanol

8. Butorphanol Tartrate

9. Dolorex

10. Moradol

11. Stadol

12. Stadol Ns

13. Torbugesic

2.2.2 Depositor-Supplied Synonyms

1. Butorphanol Tartrate

2. 58786-99-5

3. Butorphanol (+)-tartrate Salt

4. Stadol (tn)

5. Butorphanol Tartrate Salt

6. Butorphanol Tartrate (jan/usp)

7. Akos015994595

8. Hs-0001

9. Butorphanol (+)-tartrate Salt, >=99%

10. D00837

11. 786b995

12. Butorphanol Tartrate, United States Pharmacopeia (usp) Reference Standard

2.2.3 Other Synonyms

1. Butorfanol

2. Torate

3. Torbutrol

2.3 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 477.5 g/mol
Molecular Formula C25H35NO8
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count9
Rotatable Bond Count5
Exact Mass477.23626707 g/mol
Monoisotopic Mass477.23626707 g/mol
Topological Polar Surface Area159 Ų
Heavy Atom Count34
Formal Charge0
Complexity626
Isotope Atom Count0
Defined Atom Stereocenter Count5
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 2  
Drug NameButorphanol tartrate
Drug LabelButorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl) morphinan-3, 14-diol [S-(R*,R*)] 2,3 dihydroxybutanedioate (1:1) (salt). The molecul...
Active IngredientButorphanol tartrate
Dosage FormInjectable; Spray, metered
RouteNasal; Injection
Strength2mg/ml; 1mg/ml; 1mg/spray
Market StatusPrescription
CompanyBedford; Hikma Farmaceutica; Novex; Mylan; Roxane

2 of 2  
Drug NameButorphanol tartrate
Drug LabelButorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl) morphinan-3, 14-diol [S-(R*,R*)] 2,3 dihydroxybutanedioate (1:1) (salt). The molecul...
Active IngredientButorphanol tartrate
Dosage FormInjectable; Spray, metered
RouteNasal; Injection
Strength2mg/ml; 1mg/ml; 1mg/spray
Market StatusPrescription
CompanyBedford; Hikma Farmaceutica; Novex; Mylan; Roxane

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antitussive Agents

Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally. (See all compounds classified as Antitussive Agents.)


Narcotics

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)


Analgesics, Opioid

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)


Narcotic Antagonists

Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Opioid Agonist/Antagonist [EPC]; Partial Opioid Agonists [MoA]; Competitive Opioid Antagonists [MoA]

API SUPPLIERS

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Malladi Drugs & Pharmaceuticals Li...

India

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

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AbbVie Inc

U.S.A

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TAPI Technology & API Services

Israel

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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Sri Krishna Pharmaceuticals

India

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Sri Krishna Pharmaceuticals

India

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Hikal

India

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Hikal

India

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Curia

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Curia

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Merck & Co

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Merck & Co

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Abbott Laboratories

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Extractas Bioscience

Australia

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Extractas Bioscience

Australia

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Teva Pharmaceutical Industries

Israel

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Teva Pharmaceutical Industries

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01

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

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Digital Content Digital Content

Butorphanol

About the Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine an...

Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine and pseudoephedrine salts. Today, it is the leading manufacturer of APIs in the cough and cold segment. It also has a dominant presence in several therapeutic segments like antihistamines, anti-convulsants, anti-depressants and anxiolytics (CNS). Malladi exports its products to around 60 countries and over 85% of its revenue is generated from exports. Its manufacturing facilities have been approved by the FDA, EDQM, KFDA, TGA and various other regulatory agencies.
Malladi

02

  • fda
  • EDQM
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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Butorphanol Tartrate

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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Butorphanol Tartrate

About the Company : Fuan Pharmaceutical (Group) Co., Ltd. was established on February 25, 2004. The company is located in Chongqing Changshou Economic and Technological Development Zone, covering an a...

Fuan Pharmaceutical (Group) Co., Ltd. was established on February 25, 2004. The company is located in Chongqing Changshou Economic and Technological Development Zone, covering an area of about 100 acres, a construction area of over 30,000 square meters, and a registered capital of 1.189 billion yuan. It is the first company in Changshou Economic and Technological Development Zone successfully listed on the Shenzhen GEM. The company has 9 wholly-owned and holding subsidiaries. In March 2008, Fuan Pharmaceutical Group Chongqing Lybon Pharm-Tech Co
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Butorphanol

About the Company : We can help your company solve the payment problems during the trading from chinese factories. We supply you with OEM from china.We are professsionals with the competitive price an...

We can help your company solve the payment problems during the trading from chinese factories. We supply you with OEM from china.We are professsionals with the competitive price and high quality.We help you with professional regulation affair.We help you on documentation and systematizing quality control with factories. We assist you in purchasing and negotiating with various suppliers from China.We are your reliable tool and Platform around chemical ,pharmaceutical and pharm-bottle . We believe in trust and quality-reputation.
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Hikal

India
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Hikal

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Butorphanol Tartrate

About the Company : Hikal is an established provider of research services, active ingredients, intermediates and regulatory starting materials under cGMP conditions to thePharmaceutical, Crop Protecti...

Hikal is an established provider of research services, active ingredients, intermediates and regulatory starting materials under cGMP conditions to thePharmaceutical, Crop Protection and Specialty Chemicals industry. Our manufacturing facilities located in India have also been certified by the US FDA, TGA, PMDA & are ISO 9001:2008, ISO 14001, OHSAS 18001 certified and audited by global innovator, generic and biotech companies. We are a 'Responsible Care' certified company which values and respects the Intellectual property rights of our customers.Strengths: Custom Synthesis; Contract Manufacturing; Process Development, Scale-up expertise.
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TBD Pharmatech

Estonia
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Butorphanol Tartrate

About the Company : TBD Pharmatech (formerly TBD-Biodiscovery) specializes in Active Pharmaceutical Ingredients (API), advanced intermediates, and the development and production of fine chemicals. It ...

TBD Pharmatech (formerly TBD-Biodiscovery) specializes in Active Pharmaceutical Ingredients (API), advanced intermediates, and the development and production of fine chemicals. It is a Contract Development and Manufacturing Organisation (CDMO) with 16 years of experience in the market. It combines GMP-compliant production with strong R&D and extensive experience in the validation process—something that makes TBD the perfect partner to develop your ideas.
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Butorphanol

About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and...

Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a year at 70 manufacturing facilities. We rank among the leading pharmaceutical companies in the world and are active in 60 countries. Approximately 43,000 employees around the world are dedicated to our mission. Building on our strong global footprint, size and scale, Teva is reaffirming its commitment to place people at the center of our strategy, and enable as many as possible to live better, healthier days.
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Unipex

France
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Unipex

France
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Butorphanol

About the Company : Our work in the distribution sector starts and ends with the quality of human relations; first and foremost, it is trust that we want to build with you. The connections we build ar...

Our work in the distribution sector starts and ends with the quality of human relations; first and foremost, it is trust that we want to build with you. The connections we build are made to last. They are built on professionalism, respect and transparency. This is how we work, and how we have been working for a long time now, with our client partners and constituents. Unipex has been operational for 50 years, and has always remained true to its core business: the distribution of specialities. This is also why we are independent and we intend to stay that way. Our structure is simple, our commitment is absolute: we work directly with you.
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API Reference Price

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28-Mar-2022
31-Mar-2025
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

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API Imports and Exports

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

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FDF Dossiers

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01

AGGSpend
Not Confirmed
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AGGSpend
Not Confirmed

BUTORPHANOL TARTRATE

Brand Name : BUTORPHANOL NASAL SPRAY

Dosage Form : SOLUTION

Dosage Strength : 10MG/ML

Packaging : 2.5ML

Approval Date :

Application Number : 2242504

Regulatory Info :

Registration Country : Canada

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02

AGGSpend
Not Confirmed
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AGGSpend
Not Confirmed

BUTORPHANOL TARTRATE

Brand Name : STADOL PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 17857

Regulatory Info : DISCN

Registration Country : USA

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03

AGGSpend
Not Confirmed
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AGGSpend
Not Confirmed

BUTORPHANOL TARTRATE

Brand Name : STADOL

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 1MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1991-12-12

Application Number : 19890

Regulatory Info : DISCN

Registration Country : USA

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04

Farbe Firma

India
AGGSpend
Not Confirmed
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Farbe Firma

India
arrow
AGGSpend
Not Confirmed

Butorphanol

Brand Name :

Dosage Form : Injection

Dosage Strength : 2MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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05

Hikma Pharmaceuticals

United Kingdom
AGGSpend
Not Confirmed
arrow

Hikma Pharmaceuticals

United Kingdom
arrow
AGGSpend
Not Confirmed

BUTORPHANOL TARTRATE

Brand Name : BUTORPHANOL TARTRATE PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 1998-08-12

Application Number : 75045

Regulatory Info : RX

Registration Country : USA

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06

AGGSpend
Not Confirmed
arrow
arrow
AGGSpend
Not Confirmed

BUTORPHANOL TARTRATE

Brand Name : BUTORPHANOL TARTRATE PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 1997-01-23

Application Number : 74626

Regulatory Info : RX

Registration Country : USA

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07

AGGSpend
Not Confirmed
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arrow
AGGSpend
Not Confirmed

BUTORPHANOL TARTRATE

Brand Name : BUTORPHANOL TARTRATE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 1999-11-04

Application Number : 75342

Regulatory Info : DISCN

Registration Country : USA

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08

AGGSpend
Not Confirmed
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AGGSpend
Not Confirmed

BUTORPHANOL TARTRATE

Brand Name : BUTORPHANOL TARTRATE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 2000-03-20

Application Number : 75559

Regulatory Info : DISCN

Registration Country : USA

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09

AGGSpend
Not Confirmed
arrow
arrow
AGGSpend
Not Confirmed

Butorphanol

Brand Name :

Dosage Form : Injection

Dosage Strength : 4MG/2ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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10

AGGSpend
Not Confirmed
arrow
arrow
AGGSpend
Not Confirmed

Butorphanol

Brand Name : Butophan

Dosage Form : INJECTION

Dosage Strength : 1MG/ML|ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic B.E study

Registration Country : South Korea

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Butorphanol Tartrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Butorphanol Tartrate 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 Butorphanol Tartrate manufacturer or Butorphanol Tartrate supplier for your needs.

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

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

API | Excipient name

Butorphanol Tartrate

Synonyms

58786-99-5, Butorphanol (+)-tartrate salt, Stadol (tn), Butorphanol tartrate salt, Butorphanol tartrate (jan/usp), Akos015994595

Cas Number

58786-99-5

About Butorphanol Tartrate

A synthetic morphinan analgesic with narcotic antagonist action. It is used in the management of severe pain.

Butorphanol Tartrate Manufacturers

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

Butorphanol Tartrate Suppliers

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

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

Butorphanol Tartrate USDMF

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

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

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

Butorphanol Tartrate WC

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

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

Butorphanol Tartrate 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 Butorphanol Tartrate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Butorphanol Tartrate GMP

Butorphanol Tartrate 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 Butorphanol Tartrate 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 Butorphanol Tartrate GMP manufacturer or Butorphanol Tartrate GMP API supplier for your needs.

Butorphanol Tartrate CoA

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

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

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