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  • INJECTABLE;INJECTION - 6MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • POWDER;INTRAVENOUS - 100MG/VIAL

Looking for 33069-62-4 / Paclitaxel API manufacturers, exporters & distributors?

Paclitaxel manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Paclitaxel

Synonyms

33069-62-4, P88xt4is4d, Taxol, Taxol a, Yewtaxan, Abraxane

Cas Number

33069-62-4

Unique Ingredient Identifier (UNII)

P88XT4IS4D

About Paclitaxel

Nab-paclitaxel is a Cremophor EL-free, albumin-stabilized nanoparticle formulation of the natural taxane paclitaxel with antineoplastic activity. Paclitaxel binds to and stabilizes microtubules, preventing their depolymerization and so inhibiting cellular motility, mitosis, and replication. This formulation solubilizes paclitaxel without the use of the solvent Cremophor, thereby permitting the administration of larger doses of paclitaxel while avoiding the toxic effects associated with Cremophor.

Paclitaxel Manufacturers

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

Paclitaxel Suppliers

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

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

Paclitaxel USDMF

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

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

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

Paclitaxel 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 Paclitaxel Drug Master File in Japan (Paclitaxel JDMF) empowers Paclitaxel 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 Paclitaxel JDMF during the approval evaluation for pharmaceutical products. At the time of Paclitaxel 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 Paclitaxel suppliers with JDMF on PharmaCompass.

Paclitaxel KDMF

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

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

After submitting a Paclitaxel 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 Paclitaxel API can apply through the Korea Drug Master File (KDMF).

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

Paclitaxel CEP

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

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

Paclitaxel WC

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

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

Paclitaxel 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 Paclitaxel as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Paclitaxel GMP

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

Paclitaxel CoA

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

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

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