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PharmaCompass offers a list of Cephalexin Monohydrate 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 Cephalexin Monohydrate manufacturer or Cephalexin Monohydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cephalexin Monohydrate manufacturer or Cephalexin Monohydrate supplier.
PharmaCompass also assists you with knowing the Cephalexin Monohydrate API Price utilized in the formulation of products. Cephalexin Monohydrate API Price is not always fixed or binding as the Cephalexin Monohydrate Price is obtained through a variety of data sources. The Cephalexin Monohydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rilexine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rilexine, including repackagers and relabelers. The FDA regulates Rilexine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rilexine 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 Rilexine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rilexine supplier is an individual or a company that provides Rilexine active pharmaceutical ingredient (API) or Rilexine finished formulations upon request. The Rilexine suppliers may include Rilexine API manufacturers, exporters, distributors and traders.
click here to find a list of Rilexine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rilexine DMF (Drug Master File) is a document detailing the whole manufacturing process of Rilexine active pharmaceutical ingredient (API) in detail. Different forms of Rilexine DMFs exist exist since differing nations have different regulations, such as Rilexine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rilexine DMF submitted to regulatory agencies in the US is known as a USDMF. Rilexine USDMF includes data on Rilexine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rilexine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rilexine 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 Rilexine Drug Master File in Japan (Rilexine JDMF) empowers Rilexine 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 Rilexine JDMF during the approval evaluation for pharmaceutical products. At the time of Rilexine 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 Rilexine 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 Rilexine Drug Master File in Korea (Rilexine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rilexine. The MFDS reviews the Rilexine KDMF as part of the drug registration process and uses the information provided in the Rilexine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rilexine 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 Rilexine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rilexine suppliers with KDMF on PharmaCompass.
A Rilexine CEP of the European Pharmacopoeia monograph is often referred to as a Rilexine Certificate of Suitability (COS). The purpose of a Rilexine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rilexine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rilexine to their clients by showing that a Rilexine CEP has been issued for it. The manufacturer submits a Rilexine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rilexine CEP holder for the record. Additionally, the data presented in the Rilexine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rilexine DMF.
A Rilexine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rilexine 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 Rilexine suppliers with CEP (COS) on PharmaCompass.
A Rilexine written confirmation (Rilexine WC) is an official document issued by a regulatory agency to a Rilexine manufacturer, verifying that the manufacturing facility of a Rilexine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rilexine APIs or Rilexine finished pharmaceutical products to another nation, regulatory agencies frequently require a Rilexine WC (written confirmation) as part of the regulatory process.
click here to find a list of Rilexine suppliers with Written Confirmation (WC) on PharmaCompass.
Rilexine 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 Rilexine 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 Rilexine GMP manufacturer or Rilexine GMP API supplier for your needs.
A Rilexine CoA (Certificate of Analysis) is a formal document that attests to Rilexine's compliance with Rilexine specifications and serves as a tool for batch-level quality control.
Rilexine CoA mostly includes findings from lab analyses of a specific batch. For each Rilexine 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.
Rilexine may be tested according to a variety of international standards, such as European Pharmacopoeia (Rilexine EP), Rilexine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rilexine USP).
