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