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KDMF
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VMF
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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US Patents
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Regulatory FDF Prices
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
About the Company : Bioquim is a European company specializing in bulk oral and sterile APIs for the pharmaceutical industry. With over 40 years of experience, the company supplies corticosteroids, pe...
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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Penomax
Dosage Form : Film Coated Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 05/09/2008
Application Number : 20070920000088
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Penomax
Dosage Form : Film Coated Tablet
Dosage Strength : 400mg
Packaging :
Approval Date : 10/09/2015
Application Number : 20141105000107
Regulatory Info : Approved
Registration Country : Sweden
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NEWS #PharmaBuzz
25 Apr 2024
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13 Oct 2023
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27 Feb 2020
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Pivmecillinam 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 Pivmecillinam manufacturer or Pivmecillinam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pivmecillinam manufacturer or Pivmecillinam supplier.
PharmaCompass also assists you with knowing the Pivmecillinam API Price utilized in the formulation of products. Pivmecillinam API Price is not always fixed or binding as the Pivmecillinam Price is obtained through a variety of data sources. The Pivmecillinam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Coactabs (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Coactabs (TN), including repackagers and relabelers. The FDA regulates Coactabs (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Coactabs (TN) 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 Coactabs (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Coactabs (TN) supplier is an individual or a company that provides Coactabs (TN) active pharmaceutical ingredient (API) or Coactabs (TN) finished formulations upon request. The Coactabs (TN) suppliers may include Coactabs (TN) API manufacturers, exporters, distributors and traders.
click here to find a list of Coactabs (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Coactabs (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Coactabs (TN) active pharmaceutical ingredient (API) in detail. Different forms of Coactabs (TN) DMFs exist exist since differing nations have different regulations, such as Coactabs (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Coactabs (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Coactabs (TN) USDMF includes data on Coactabs (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Coactabs (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Coactabs (TN) 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 Coactabs (TN) Drug Master File in Japan (Coactabs (TN) JDMF) empowers Coactabs (TN) 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 Coactabs (TN) JDMF during the approval evaluation for pharmaceutical products. At the time of Coactabs (TN) 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 Coactabs (TN) suppliers with JDMF on PharmaCompass.
A Coactabs (TN) CEP of the European Pharmacopoeia monograph is often referred to as a Coactabs (TN) Certificate of Suitability (COS). The purpose of a Coactabs (TN) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Coactabs (TN) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Coactabs (TN) to their clients by showing that a Coactabs (TN) CEP has been issued for it. The manufacturer submits a Coactabs (TN) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Coactabs (TN) CEP holder for the record. Additionally, the data presented in the Coactabs (TN) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Coactabs (TN) DMF.
A Coactabs (TN) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Coactabs (TN) CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Coactabs (TN) suppliers with CEP (COS) on PharmaCompass.
A Coactabs (TN) written confirmation (Coactabs (TN) WC) is an official document issued by a regulatory agency to a Coactabs (TN) manufacturer, verifying that the manufacturing facility of a Coactabs (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Coactabs (TN) APIs or Coactabs (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Coactabs (TN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Coactabs (TN) 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 Coactabs (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Coactabs (TN) 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 Coactabs (TN) 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 Coactabs (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Coactabs (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Coactabs (TN) suppliers with NDC on PharmaCompass.
Coactabs (TN) 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 Coactabs (TN) 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 Coactabs (TN) GMP manufacturer or Coactabs (TN) GMP API supplier for your needs.
A Coactabs (TN) CoA (Certificate of Analysis) is a formal document that attests to Coactabs (TN)'s compliance with Coactabs (TN) specifications and serves as a tool for batch-level quality control.
Coactabs (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Coactabs (TN) 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.
Coactabs (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Coactabs (TN) EP), Coactabs (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Coactabs (TN) USP).
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