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PharmaCompass offers a list of Desflurane 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 Desflurane manufacturer or Desflurane supplier for your needs.
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A MolPort-001-776-387 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MolPort-001-776-387, including repackagers and relabelers. The FDA regulates MolPort-001-776-387 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MolPort-001-776-387 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 MolPort-001-776-387 supplier is an individual or a company that provides MolPort-001-776-387 active pharmaceutical ingredient (API) or MolPort-001-776-387 finished formulations upon request. The MolPort-001-776-387 suppliers may include MolPort-001-776-387 API manufacturers, exporters, distributors and traders.
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A MolPort-001-776-387 DMF (Drug Master File) is a document detailing the whole manufacturing process of MolPort-001-776-387 active pharmaceutical ingredient (API) in detail. Different forms of MolPort-001-776-387 DMFs exist exist since differing nations have different regulations, such as MolPort-001-776-387 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MolPort-001-776-387 DMF submitted to regulatory agencies in the US is known as a USDMF. MolPort-001-776-387 USDMF includes data on MolPort-001-776-387's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MolPort-001-776-387 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 MolPort-001-776-387 Drug Master File in Japan (MolPort-001-776-387 JDMF) empowers MolPort-001-776-387 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 MolPort-001-776-387 JDMF during the approval evaluation for pharmaceutical products. At the time of MolPort-001-776-387 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 MolPort-001-776-387 Drug Master File in Korea (MolPort-001-776-387 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MolPort-001-776-387. The MFDS reviews the MolPort-001-776-387 KDMF as part of the drug registration process and uses the information provided in the MolPort-001-776-387 KDMF to evaluate the safety and efficacy of the drug.
After submitting a MolPort-001-776-387 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 MolPort-001-776-387 API can apply through the Korea Drug Master File (KDMF).
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MolPort-001-776-387 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 MolPort-001-776-387 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 MolPort-001-776-387 GMP manufacturer or MolPort-001-776-387 GMP API supplier for your needs.
A MolPort-001-776-387 CoA (Certificate of Analysis) is a formal document that attests to MolPort-001-776-387's compliance with MolPort-001-776-387 specifications and serves as a tool for batch-level quality control.
MolPort-001-776-387 CoA mostly includes findings from lab analyses of a specific batch. For each MolPort-001-776-387 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.
MolPort-001-776-387 may be tested according to a variety of international standards, such as European Pharmacopoeia (MolPort-001-776-387 EP), MolPort-001-776-387 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MolPort-001-776-387 USP).