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