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South Africa
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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;SUBLINGUAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 22117
DOSAGE - TABLET;SUBLINGUAL - EQ 2.5MG BASE
USFDA APPLICATION NUMBER - 22117
DOSAGE - TABLET;SUBLINGUAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 22117
Related Excipient Companies
Rochem International Inc
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ABOUT THIS PAGE
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PharmaCompass offers a list of Asenapine Maleate 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 Asenapine Maleate manufacturer or Asenapine Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Asenapine Maleate manufacturer or Asenapine Maleate supplier.
PharmaCompass also assists you with knowing the Asenapine Maleate API Price utilized in the formulation of products. Asenapine Maleate API Price is not always fixed or binding as the Asenapine Maleate Price is obtained through a variety of data sources. The Asenapine Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A saphris manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of saphris, including repackagers and relabelers. The FDA regulates saphris manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. saphris 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 saphris manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A saphris supplier is an individual or a company that provides saphris active pharmaceutical ingredient (API) or saphris finished formulations upon request. The saphris suppliers may include saphris API manufacturers, exporters, distributors and traders.
click here to find a list of saphris suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A saphris DMF (Drug Master File) is a document detailing the whole manufacturing process of saphris active pharmaceutical ingredient (API) in detail. Different forms of saphris DMFs exist exist since differing nations have different regulations, such as saphris USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A saphris DMF submitted to regulatory agencies in the US is known as a USDMF. saphris USDMF includes data on saphris's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The saphris USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of saphris 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 saphris Drug Master File in Japan (saphris JDMF) empowers saphris 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 saphris JDMF during the approval evaluation for pharmaceutical products. At the time of saphris 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 saphris suppliers with JDMF on PharmaCompass.
A saphris written confirmation (saphris WC) is an official document issued by a regulatory agency to a saphris manufacturer, verifying that the manufacturing facility of a saphris active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting saphris APIs or saphris finished pharmaceutical products to another nation, regulatory agencies frequently require a saphris WC (written confirmation) as part of the regulatory process.
click here to find a list of saphris 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 saphris as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for saphris 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 saphris 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 saphris and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a saphris NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of saphris suppliers with NDC on PharmaCompass.
saphris 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 saphris 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 saphris GMP manufacturer or saphris GMP API supplier for your needs.
A saphris CoA (Certificate of Analysis) is a formal document that attests to saphris's compliance with saphris specifications and serves as a tool for batch-level quality control.
saphris CoA mostly includes findings from lab analyses of a specific batch. For each saphris 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.
saphris may be tested according to a variety of international standards, such as European Pharmacopoeia (saphris EP), saphris JP (Japanese Pharmacopeia) and the US Pharmacopoeia (saphris USP).
