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