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USDMF
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API SUPPLIERS
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ABOUT THIS PAGE
A Tylosin Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tylosin Phosphate, including repackagers and relabelers. The FDA regulates Tylosin Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tylosin Phosphate 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 Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tylosin Phosphate supplier is an individual or a company that provides Tylosin Phosphate active pharmaceutical ingredient (API) or Tylosin Phosphate finished formulations upon request. The Tylosin Phosphate suppliers may include Tylosin Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Tylosin Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tylosin Phosphate CEP of the European Pharmacopoeia monograph is often referred to as a Tylosin Phosphate Certificate of Suitability (COS). The purpose of a Tylosin Phosphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tylosin Phosphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tylosin Phosphate to their clients by showing that a Tylosin Phosphate CEP has been issued for it. The manufacturer submits a Tylosin Phosphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tylosin Phosphate CEP holder for the record. Additionally, the data presented in the Tylosin Phosphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tylosin Phosphate DMF.
A Tylosin Phosphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tylosin Phosphate 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 Phosphate 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 Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tylosin Phosphate 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 Phosphate 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 Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tylosin Phosphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tylosin Phosphate suppliers with NDC on PharmaCompass.
Tylosin Phosphate 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 Phosphate 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 Phosphate GMP manufacturer or Tylosin Phosphate GMP API supplier for your needs.
A Tylosin Phosphate CoA (Certificate of Analysis) is a formal document that attests to Tylosin Phosphate's compliance with Tylosin Phosphate specifications and serves as a tool for batch-level quality control.
Tylosin Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Tylosin Phosphate 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 Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Tylosin Phosphate EP), Tylosin Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tylosin Phosphate USP).
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