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PharmaCompass offers a list of NCGC00181764-01 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 NCGC00181764-01 manufacturer or NCGC00181764-01 supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred NCGC00181764-01 manufacturer or NCGC00181764-01 supplier.
PharmaCompass also assists you with knowing the NCGC00181764-01 API Price utilized in the formulation of products. NCGC00181764-01 API Price is not always fixed or binding as the NCGC00181764-01 Price is obtained through a variety of data sources. The NCGC00181764-01 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A NCGC00181764-01 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NCGC00181764-01, including repackagers and relabelers. The FDA regulates NCGC00181764-01 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NCGC00181764-01 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A NCGC00181764-01 supplier is an individual or a company that provides NCGC00181764-01 active pharmaceutical ingredient (API) or NCGC00181764-01 finished formulations upon request. The NCGC00181764-01 suppliers may include NCGC00181764-01 API manufacturers, exporters, distributors and traders.
click here to find a list of NCGC00181764-01 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 NCGC00181764-01 Drug Master File in Japan (NCGC00181764-01 JDMF) empowers NCGC00181764-01 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 NCGC00181764-01 JDMF during the approval evaluation for pharmaceutical products. At the time of NCGC00181764-01 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 NCGC00181764-01 suppliers with JDMF on PharmaCompass.
NCGC00181764-01 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 NCGC00181764-01 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 NCGC00181764-01 GMP manufacturer or NCGC00181764-01 GMP API supplier for your needs.
A NCGC00181764-01 CoA (Certificate of Analysis) is a formal document that attests to NCGC00181764-01's compliance with NCGC00181764-01 specifications and serves as a tool for batch-level quality control.
NCGC00181764-01 CoA mostly includes findings from lab analyses of a specific batch. For each NCGC00181764-01 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.
NCGC00181764-01 may be tested according to a variety of international standards, such as European Pharmacopoeia (NCGC00181764-01 EP), NCGC00181764-01 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (NCGC00181764-01 USP).