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South Africa
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USDMF
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Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
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Drugs in Development
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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
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ABOUT THIS PAGE
A Asenapine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Asenapine Maleate, including repackagers and relabelers. The FDA regulates Asenapine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Asenapine Maleate 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 Asenapine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Asenapine Maleate supplier is an individual or a company that provides Asenapine Maleate active pharmaceutical ingredient (API) or Asenapine Maleate finished formulations upon request. The Asenapine Maleate suppliers may include Asenapine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Asenapine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Asenapine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Asenapine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Asenapine Maleate DMFs exist exist since differing nations have different regulations, such as Asenapine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Asenapine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Asenapine Maleate USDMF includes data on Asenapine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Asenapine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Asenapine Maleate 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 Asenapine Maleate Drug Master File in Japan (Asenapine Maleate JDMF) empowers Asenapine Maleate 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 Asenapine Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Asenapine Maleate 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 Asenapine Maleate suppliers with JDMF on PharmaCompass.
A Asenapine Maleate written confirmation (Asenapine Maleate WC) is an official document issued by a regulatory agency to a Asenapine Maleate manufacturer, verifying that the manufacturing facility of a Asenapine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Asenapine Maleate APIs or Asenapine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Asenapine Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Asenapine Maleate 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 Asenapine Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Asenapine Maleate 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 Asenapine Maleate 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 Asenapine Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Asenapine Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Asenapine Maleate suppliers with NDC on PharmaCompass.
Asenapine Maleate 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 Asenapine Maleate 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 Asenapine Maleate GMP manufacturer or Asenapine Maleate GMP API supplier for your needs.
A Asenapine Maleate CoA (Certificate of Analysis) is a formal document that attests to Asenapine Maleate's compliance with Asenapine Maleate specifications and serves as a tool for batch-level quality control.
Asenapine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Asenapine Maleate 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.
Asenapine Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Asenapine Maleate EP), Asenapine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Asenapine Maleate USP).
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