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