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PharmaCompass offers a list of Erythromycin Lactobionate 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 Lactobionate manufacturer or Erythromycin Lactobionate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Erythromycin Lactobionate manufacturer or Erythromycin Lactobionate supplier.
PharmaCompass also assists you with knowing the Erythromycin Lactobionate API Price utilized in the formulation of products. Erythromycin Lactobionate API Price is not always fixed or binding as the Erythromycin Lactobionate Price is obtained through a variety of data sources. The Erythromycin Lactobionate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A C37H67NO13.C12H22O12 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C37H67NO13.C12H22O12, including repackagers and relabelers. The FDA regulates C37H67NO13.C12H22O12 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C37H67NO13.C12H22O12 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A C37H67NO13.C12H22O12 supplier is an individual or a company that provides C37H67NO13.C12H22O12 active pharmaceutical ingredient (API) or C37H67NO13.C12H22O12 finished formulations upon request. The C37H67NO13.C12H22O12 suppliers may include C37H67NO13.C12H22O12 API manufacturers, exporters, distributors and traders.
click here to find a list of C37H67NO13.C12H22O12 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A C37H67NO13.C12H22O12 DMF (Drug Master File) is a document detailing the whole manufacturing process of C37H67NO13.C12H22O12 active pharmaceutical ingredient (API) in detail. Different forms of C37H67NO13.C12H22O12 DMFs exist exist since differing nations have different regulations, such as C37H67NO13.C12H22O12 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A C37H67NO13.C12H22O12 DMF submitted to regulatory agencies in the US is known as a USDMF. C37H67NO13.C12H22O12 USDMF includes data on C37H67NO13.C12H22O12's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The C37H67NO13.C12H22O12 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 Drug Master File in Japan (C37H67NO13.C12H22O12 JDMF) empowers C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 JDMF during the approval evaluation for pharmaceutical products. At the time of C37H67NO13.C12H22O12 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a C37H67NO13.C12H22O12 Drug Master File in Korea (C37H67NO13.C12H22O12 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of C37H67NO13.C12H22O12. The MFDS reviews the C37H67NO13.C12H22O12 KDMF as part of the drug registration process and uses the information provided in the C37H67NO13.C12H22O12 KDMF to evaluate the safety and efficacy of the drug.
After submitting a C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of C37H67NO13.C12H22O12 suppliers with KDMF 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 C37H67NO13.C12H22O12 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a C37H67NO13.C12H22O12 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of C37H67NO13.C12H22O12 suppliers with NDC on PharmaCompass.
C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 GMP manufacturer or C37H67NO13.C12H22O12 GMP API supplier for your needs.
A C37H67NO13.C12H22O12 CoA (Certificate of Analysis) is a formal document that attests to C37H67NO13.C12H22O12's compliance with C37H67NO13.C12H22O12 specifications and serves as a tool for batch-level quality control.
C37H67NO13.C12H22O12 CoA mostly includes findings from lab analyses of a specific batch. For each C37H67NO13.C12H22O12 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.
C37H67NO13.C12H22O12 may be tested according to a variety of international standards, such as European Pharmacopoeia (C37H67NO13.C12H22O12 EP), C37H67NO13.C12H22O12 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (C37H67NO13.C12H22O12 USP).
