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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 22465
DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22465
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ABOUT THIS PAGE
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PharmaCompass offers a list of Pazopanib Hydrochloride 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 Pazopanib Hydrochloride manufacturer or Pazopanib Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pazopanib Hydrochloride manufacturer or Pazopanib Hydrochloride supplier.
PharmaCompass also assists you with knowing the Pazopanib Hydrochloride API Price utilized in the formulation of products. Pazopanib Hydrochloride API Price is not always fixed or binding as the Pazopanib Hydrochloride Price is obtained through a variety of data sources. The Pazopanib Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A X3177 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of X3177, including repackagers and relabelers. The FDA regulates X3177 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. X3177 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 X3177 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A X3177 supplier is an individual or a company that provides X3177 active pharmaceutical ingredient (API) or X3177 finished formulations upon request. The X3177 suppliers may include X3177 API manufacturers, exporters, distributors and traders.
click here to find a list of X3177 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A X3177 DMF (Drug Master File) is a document detailing the whole manufacturing process of X3177 active pharmaceutical ingredient (API) in detail. Different forms of X3177 DMFs exist exist since differing nations have different regulations, such as X3177 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A X3177 DMF submitted to regulatory agencies in the US is known as a USDMF. X3177 USDMF includes data on X3177's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The X3177 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of X3177 suppliers with USDMF on PharmaCompass.
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 X3177 Drug Master File in Japan (X3177 JDMF) empowers X3177 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 X3177 JDMF during the approval evaluation for pharmaceutical products. At the time of X3177 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 X3177 suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a X3177 Drug Master File in Korea (X3177 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of X3177. The MFDS reviews the X3177 KDMF as part of the drug registration process and uses the information provided in the X3177 KDMF to evaluate the safety and efficacy of the drug.
After submitting a X3177 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 X3177 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of X3177 suppliers with KDMF on PharmaCompass.
A X3177 written confirmation (X3177 WC) is an official document issued by a regulatory agency to a X3177 manufacturer, verifying that the manufacturing facility of a X3177 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting X3177 APIs or X3177 finished pharmaceutical products to another nation, regulatory agencies frequently require a X3177 WC (written confirmation) as part of the regulatory process.
click here to find a list of X3177 suppliers with Written Confirmation (WC) 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 X3177 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for X3177 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 X3177 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 X3177 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a X3177 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of X3177 suppliers with NDC on PharmaCompass.
X3177 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 X3177 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 X3177 GMP manufacturer or X3177 GMP API supplier for your needs.
A X3177 CoA (Certificate of Analysis) is a formal document that attests to X3177's compliance with X3177 specifications and serves as a tool for batch-level quality control.
X3177 CoA mostly includes findings from lab analyses of a specific batch. For each X3177 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.
X3177 may be tested according to a variety of international standards, such as European Pharmacopoeia (X3177 EP), X3177 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (X3177 USP).
