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