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