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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35732
Submission : 2021-03-31
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36037
Submission : 2021-06-30
Status :
Type : II
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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.
CAS Number : 20191-74-6
End Use API : Pazopanib Hydrochloride
About The Company : Valsynthese, a privately held CDMO, is a member of the SSE Group. Headquartered in Brig, Switzerland, it has a broad international reach. With over a century of...
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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**Federa...DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Pazopanib Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pazopanib Hydrochloride, including repackagers and relabelers. The FDA regulates Pazopanib Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pazopanib Hydrochloride 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 Pazopanib Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pazopanib Hydrochloride supplier is an individual or a company that provides Pazopanib Hydrochloride active pharmaceutical ingredient (API) or Pazopanib Hydrochloride finished formulations upon request. The Pazopanib Hydrochloride suppliers may include Pazopanib Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Pazopanib Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pazopanib Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Pazopanib Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Pazopanib Hydrochloride DMFs exist exist since differing nations have different regulations, such as Pazopanib Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pazopanib Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Pazopanib Hydrochloride USDMF includes data on Pazopanib Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pazopanib Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pazopanib Hydrochloride 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 Pazopanib Hydrochloride Drug Master File in Japan (Pazopanib Hydrochloride JDMF) empowers Pazopanib Hydrochloride 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 Pazopanib Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Pazopanib Hydrochloride 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 Pazopanib Hydrochloride 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 Pazopanib Hydrochloride Drug Master File in Korea (Pazopanib Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pazopanib Hydrochloride. The MFDS reviews the Pazopanib Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Pazopanib Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pazopanib Hydrochloride 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 Pazopanib Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pazopanib Hydrochloride suppliers with KDMF on PharmaCompass.
A Pazopanib Hydrochloride written confirmation (Pazopanib Hydrochloride WC) is an official document issued by a regulatory agency to a Pazopanib Hydrochloride manufacturer, verifying that the manufacturing facility of a Pazopanib Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pazopanib Hydrochloride APIs or Pazopanib Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Pazopanib Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Pazopanib Hydrochloride 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 Pazopanib Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pazopanib Hydrochloride 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 Pazopanib Hydrochloride 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 Pazopanib Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pazopanib Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pazopanib Hydrochloride suppliers with NDC on PharmaCompass.
Pazopanib Hydrochloride 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 Pazopanib Hydrochloride 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 Pazopanib Hydrochloride GMP manufacturer or Pazopanib Hydrochloride GMP API supplier for your needs.
A Pazopanib Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Pazopanib Hydrochloride's compliance with Pazopanib Hydrochloride specifications and serves as a tool for batch-level quality control.
Pazopanib Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Pazopanib Hydrochloride 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.
Pazopanib Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Pazopanib Hydrochloride EP), Pazopanib Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pazopanib Hydrochloride USP).
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