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1. Fradizine
2. Hydrochloride, Tylosin
3. Tartrate, Tylosin
4. Tylan
5. Tylosin
6. Tylosin Hydrochloride
7. Tylosin Tartrate
8. Tylosin Tartrate (salt)
9. Tylosine
1. Pharmasin
2. Tylosin Tartrate
3. 1405-54-5
4. Schembl14973663
Molecular Weight | 1066.2 g/mol |
---|---|
Molecular Formula | C50H83NO23 |
Hydrogen Bond Donor Count | 9 |
Hydrogen Bond Acceptor Count | 24 |
Rotatable Bond Count | 16 |
Exact Mass | 1065.53558789 g/mol |
Monoisotopic Mass | 1065.53558789 g/mol |
Topological Polar Surface Area | 354 Ų |
Heavy Atom Count | 74 |
Formal Charge | 0 |
Complexity | 1700 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 21 |
Undefined Atom Stereocenter Count | 2 |
Defined Bond Stereocenter Count | 2 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25211
Submission : 2011-08-05
Status : Inactive
Type : II
Tylosin Tartrate For Veterinary Use
Certificate Number : R1-CEP 2007-304 - Rev 01
Status : Valid
Issue Date : 2018-03-21
Type : Chemical and TSE
Substance Number : 1274
Tylosin Tartrate For Veterinary Use
Certificate Number : R1-CEP 2003-258 - Rev 01
Status : Valid
Issue Date : 2018-02-26
Type : Chemical
Substance Number : 1274
Tylosin Tartrate For Veterinary Use
Certificate Number : CEP 2001-016 - Rev 04
Status : Valid
Issue Date : 2024-10-04
Type : Chemical
Substance Number : 1274
Tylosin Tartrate For Veterinary Use
Certificate Number : R1-CEP 2014-122 - Rev 00
Status : Valid
Issue Date : 2021-10-20
Type : Chemical
Substance Number : 1274
Tylosin Tartrate For Veterinary Use, Granule
Certificate Number : R0-CEP 2020-329 - Rev 00
Status : Valid
Issue Date : 2022-11-02
Type : Chemical
Substance Number : 1274
Tylosin Tartrate For Veterinary Use
Certificate Number : R0-CEP 2021-146 - Rev 00
Status : Valid
Issue Date : 2022-10-21
Type : Chemical
Substance Number : 1274
Tylosin Tartrate For Veterinary Use
Certificate Number : R0-CEP 2019-198 - Rev 00
Status : Valid
Issue Date : 2022-07-21
Type : Chemical
Substance Number : 1274
Tylosin Tartrate For Veterinary Use
Certificate Number : CEP 2014-328 - Rev 02
Status : Valid
Issue Date : 2024-05-14
Type : Chemical
Substance Number : 1274
Tylosin Tartrate For Veterinary Use, Granular (W...
Certificate Number : CEP 2024-226 - Rev 00
Status : Valid
Issue Date : 2024-10-17
Type : Chemical
Substance Number : 1274
Tylosin Tartrate For Veterinary Use
Certificate Number : CEP 2015-379 - Rev 03
Status : Valid
Issue Date : 2024-07-31
Type : Chemical
Substance Number : 1274
NDC Package Code : 38779-3170
Start Marketing Date : 2022-06-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 62635-003
Start Marketing Date : 2022-03-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 86098-0001
Start Marketing Date : 2019-07-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
VMF Number : 5800
Submission : 2004-04-12
Status : Active
Type : II
VMF Number : 5802
Submission : 2004-04-20
Status : Active
Type : II
VMF Number : 5690
Submission : 2000-10-11
Status : Inactive
Type : II
VMF Number : 5712
Submission : 2001-02-26
Status : Inactive
Type : II
VMF Number : 6032
Submission : 2012-12-11
Status : Active
Type : II
VMF Number : 6058
Submission : 2013-09-04
Status : Active
Type : II
VMF Number : 6346
Submission : 2019-10-25
Status : Active
Type : II
VMF Number : 6108
Submission : 2015-08-05
Status : Active
Type : II
VMF Number : 6190
Submission : 2017-05-15
Status : Active
Type : II
VMF Number : 6056
Submission : 2013-08-29
Status : Active
Type : II
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PharmaCompass offers a list of Tylosin 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 Tylosin Tartrate manufacturer or Tylosin Tartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tylosin Tartrate manufacturer or Tylosin Tartrate supplier.
PharmaCompass also assists you with knowing the Tylosin Tartrate API Price utilized in the formulation of products. Tylosin Tartrate API Price is not always fixed or binding as the Tylosin Tartrate Price is obtained through a variety of data sources. The Tylosin Tartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tylosin Tartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tylosin Tartrate, including repackagers and relabelers. The FDA regulates Tylosin Tartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tylosin 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 Tylosin Tartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tylosin Tartrate supplier is an individual or a company that provides Tylosin Tartrate active pharmaceutical ingredient (API) or Tylosin Tartrate finished formulations upon request. The Tylosin Tartrate suppliers may include Tylosin Tartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Tylosin Tartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tylosin Tartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Tylosin Tartrate active pharmaceutical ingredient (API) in detail. Different forms of Tylosin Tartrate DMFs exist exist since differing nations have different regulations, such as Tylosin Tartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tylosin Tartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Tylosin Tartrate USDMF includes data on Tylosin Tartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tylosin Tartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tylosin Tartrate suppliers with USDMF on PharmaCompass.
A Tylosin Tartrate CEP of the European Pharmacopoeia monograph is often referred to as a Tylosin Tartrate Certificate of Suitability (COS). The purpose of a Tylosin Tartrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tylosin Tartrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tylosin Tartrate to their clients by showing that a Tylosin Tartrate CEP has been issued for it. The manufacturer submits a Tylosin Tartrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tylosin Tartrate CEP holder for the record. Additionally, the data presented in the Tylosin Tartrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tylosin Tartrate DMF.
A Tylosin Tartrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tylosin Tartrate 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 Tylosin Tartrate suppliers with CEP (COS) on PharmaCompass.
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 Tylosin Tartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tylosin Tartrate API and other APIs are published in this directory by the FDA.
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 Tylosin 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.
The NDC directory also contains data on finished compounded human drug products that contain Tylosin Tartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tylosin Tartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tylosin Tartrate suppliers with NDC on PharmaCompass.
Tylosin 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 Tylosin 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 Tylosin Tartrate GMP manufacturer or Tylosin Tartrate GMP API supplier for your needs.
A Tylosin Tartrate CoA (Certificate of Analysis) is a formal document that attests to Tylosin Tartrate's compliance with Tylosin Tartrate specifications and serves as a tool for batch-level quality control.
Tylosin Tartrate CoA mostly includes findings from lab analyses of a specific batch. For each Tylosin 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.
Tylosin Tartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Tylosin Tartrate EP), Tylosin Tartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tylosin Tartrate USP).