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