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Looking for 171228-49-2 / Posaconazole API manufacturers, exporters & distributors?

Posaconazole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Posaconazole

Synonyms

171228-49-2, Noxafil, Sch 56592, Sch-56592, Posaconazole sp, Sch56592

Cas Number

171228-49-2

Unique Ingredient Identifier (UNII)

6TK1G07BHZ

About Posaconazole

Posaconazole is a broad-spectrum, second generation, triazole compound with antifungal activity. Posaconazole strongly inhibits 14-alpha demethylase, a cytochrome P450-dependent enzyme. Inhibition of 14-alpha-demethylase prevents the conversion of lanosterol to ergosterol, an important component of the fungal cell wall. Inhibition of ergosterol synthesis changes the fungal cell membrane composition and integrity, alters membrane permeability and eventually leads to fungal cell lysis. Compared to other azole antifungals, posaconazole is a significantly more potent inhibitor of sterol 14-alpha demethylase.

Posaconazole Manufacturers

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

Posaconazole Suppliers

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

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

Posaconazole USDMF

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

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

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

Posaconazole KDMF

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

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

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

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

Posaconazole WC

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

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

Posaconazole 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 Posaconazole as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Posaconazole GMP

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

Posaconazole CoA

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

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

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