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API SUPPLIERS
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
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CEP/COS
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SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
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ABOUT THIS PAGE
A Pimobendan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pimobendan, including repackagers and relabelers. The FDA regulates Pimobendan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pimobendan 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 Pimobendan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pimobendan supplier is an individual or a company that provides Pimobendan active pharmaceutical ingredient (API) or Pimobendan finished formulations upon request. The Pimobendan suppliers may include Pimobendan API manufacturers, exporters, distributors and traders.
click here to find a list of Pimobendan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Pimobendan Drug Master File in Japan (Pimobendan JDMF) empowers Pimobendan 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 Pimobendan JDMF during the approval evaluation for pharmaceutical products. At the time of Pimobendan 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 Pimobendan suppliers with JDMF on PharmaCompass.
A Pimobendan CEP of the European Pharmacopoeia monograph is often referred to as a Pimobendan Certificate of Suitability (COS). The purpose of a Pimobendan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pimobendan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pimobendan to their clients by showing that a Pimobendan CEP has been issued for it. The manufacturer submits a Pimobendan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pimobendan CEP holder for the record. Additionally, the data presented in the Pimobendan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pimobendan DMF.
A Pimobendan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pimobendan 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 Pimobendan suppliers with CEP (COS) 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 Pimobendan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pimobendan 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 Pimobendan 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 Pimobendan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pimobendan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pimobendan suppliers with NDC on PharmaCompass.
Pimobendan 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 Pimobendan 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 Pimobendan GMP manufacturer or Pimobendan GMP API supplier for your needs.
A Pimobendan CoA (Certificate of Analysis) is a formal document that attests to Pimobendan's compliance with Pimobendan specifications and serves as a tool for batch-level quality control.
Pimobendan CoA mostly includes findings from lab analyses of a specific batch. For each Pimobendan 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.
Pimobendan may be tested according to a variety of international standards, such as European Pharmacopoeia (Pimobendan EP), Pimobendan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pimobendan USP).
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