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PharmaCompass offers a list of Caffeine 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 Caffeine manufacturer or Caffeine supplier for your needs.
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PharmaCompass also assists you with knowing the Caffeine API Price utilized in the formulation of products. Caffeine API Price is not always fixed or binding as the Caffeine Price is obtained through a variety of data sources. The Caffeine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 07E4FB58-FD79-4175-8E3D-05BF96954522 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 07E4FB58-FD79-4175-8E3D-05BF96954522, including repackagers and relabelers. The FDA regulates 07E4FB58-FD79-4175-8E3D-05BF96954522 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 07E4FB58-FD79-4175-8E3D-05BF96954522 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 07E4FB58-FD79-4175-8E3D-05BF96954522 supplier is an individual or a company that provides 07E4FB58-FD79-4175-8E3D-05BF96954522 active pharmaceutical ingredient (API) or 07E4FB58-FD79-4175-8E3D-05BF96954522 finished formulations upon request. The 07E4FB58-FD79-4175-8E3D-05BF96954522 suppliers may include 07E4FB58-FD79-4175-8E3D-05BF96954522 API manufacturers, exporters, distributors and traders.
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A 07E4FB58-FD79-4175-8E3D-05BF96954522 DMF (Drug Master File) is a document detailing the whole manufacturing process of 07E4FB58-FD79-4175-8E3D-05BF96954522 active pharmaceutical ingredient (API) in detail. Different forms of 07E4FB58-FD79-4175-8E3D-05BF96954522 DMFs exist exist since differing nations have different regulations, such as 07E4FB58-FD79-4175-8E3D-05BF96954522 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 07E4FB58-FD79-4175-8E3D-05BF96954522 DMF submitted to regulatory agencies in the US is known as a USDMF. 07E4FB58-FD79-4175-8E3D-05BF96954522 USDMF includes data on 07E4FB58-FD79-4175-8E3D-05BF96954522's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 07E4FB58-FD79-4175-8E3D-05BF96954522 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 07E4FB58-FD79-4175-8E3D-05BF96954522 Drug Master File in Japan (07E4FB58-FD79-4175-8E3D-05BF96954522 JDMF) empowers 07E4FB58-FD79-4175-8E3D-05BF96954522 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 07E4FB58-FD79-4175-8E3D-05BF96954522 JDMF during the approval evaluation for pharmaceutical products. At the time of 07E4FB58-FD79-4175-8E3D-05BF96954522 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 07E4FB58-FD79-4175-8E3D-05BF96954522 Drug Master File in Korea (07E4FB58-FD79-4175-8E3D-05BF96954522 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 07E4FB58-FD79-4175-8E3D-05BF96954522. The MFDS reviews the 07E4FB58-FD79-4175-8E3D-05BF96954522 KDMF as part of the drug registration process and uses the information provided in the 07E4FB58-FD79-4175-8E3D-05BF96954522 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 07E4FB58-FD79-4175-8E3D-05BF96954522 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 07E4FB58-FD79-4175-8E3D-05BF96954522 API can apply through the Korea Drug Master File (KDMF).
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A 07E4FB58-FD79-4175-8E3D-05BF96954522 CEP of the European Pharmacopoeia monograph is often referred to as a 07E4FB58-FD79-4175-8E3D-05BF96954522 Certificate of Suitability (COS). The purpose of a 07E4FB58-FD79-4175-8E3D-05BF96954522 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 07E4FB58-FD79-4175-8E3D-05BF96954522 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 07E4FB58-FD79-4175-8E3D-05BF96954522 to their clients by showing that a 07E4FB58-FD79-4175-8E3D-05BF96954522 CEP has been issued for it. The manufacturer submits a 07E4FB58-FD79-4175-8E3D-05BF96954522 CEP (COS) as part of the market authorization procedure, and it takes on the role of a 07E4FB58-FD79-4175-8E3D-05BF96954522 CEP holder for the record. Additionally, the data presented in the 07E4FB58-FD79-4175-8E3D-05BF96954522 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 07E4FB58-FD79-4175-8E3D-05BF96954522 DMF.
A 07E4FB58-FD79-4175-8E3D-05BF96954522 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 07E4FB58-FD79-4175-8E3D-05BF96954522 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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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 07E4FB58-FD79-4175-8E3D-05BF96954522 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 07E4FB58-FD79-4175-8E3D-05BF96954522 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 07E4FB58-FD79-4175-8E3D-05BF96954522 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 07E4FB58-FD79-4175-8E3D-05BF96954522 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 07E4FB58-FD79-4175-8E3D-05BF96954522 NDC to their finished compounded human drug products, they may choose to do so.
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07E4FB58-FD79-4175-8E3D-05BF96954522 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 07E4FB58-FD79-4175-8E3D-05BF96954522 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 07E4FB58-FD79-4175-8E3D-05BF96954522 GMP manufacturer or 07E4FB58-FD79-4175-8E3D-05BF96954522 GMP API supplier for your needs.
A 07E4FB58-FD79-4175-8E3D-05BF96954522 CoA (Certificate of Analysis) is a formal document that attests to 07E4FB58-FD79-4175-8E3D-05BF96954522's compliance with 07E4FB58-FD79-4175-8E3D-05BF96954522 specifications and serves as a tool for batch-level quality control.
07E4FB58-FD79-4175-8E3D-05BF96954522 CoA mostly includes findings from lab analyses of a specific batch. For each 07E4FB58-FD79-4175-8E3D-05BF96954522 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.
07E4FB58-FD79-4175-8E3D-05BF96954522 may be tested according to a variety of international standards, such as European Pharmacopoeia (07E4FB58-FD79-4175-8E3D-05BF96954522 EP), 07E4FB58-FD79-4175-8E3D-05BF96954522 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (07E4FB58-FD79-4175-8E3D-05BF96954522 USP).