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