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