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API SUPPLIERS
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INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Mitiglinide Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitiglinide Calcium, including repackagers and relabelers. The FDA regulates Mitiglinide Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitiglinide Calcium 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 Mitiglinide Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitiglinide Calcium supplier is an individual or a company that provides Mitiglinide Calcium active pharmaceutical ingredient (API) or Mitiglinide Calcium finished formulations upon request. The Mitiglinide Calcium suppliers may include Mitiglinide Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Mitiglinide Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mitiglinide Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Mitiglinide Calcium active pharmaceutical ingredient (API) in detail. Different forms of Mitiglinide Calcium DMFs exist exist since differing nations have different regulations, such as Mitiglinide Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mitiglinide Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Mitiglinide Calcium USDMF includes data on Mitiglinide Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mitiglinide Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mitiglinide Calcium 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 Mitiglinide Calcium Drug Master File in Japan (Mitiglinide Calcium JDMF) empowers Mitiglinide Calcium 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 Mitiglinide Calcium JDMF during the approval evaluation for pharmaceutical products. At the time of Mitiglinide Calcium 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 Mitiglinide Calcium 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 Mitiglinide Calcium Drug Master File in Korea (Mitiglinide Calcium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mitiglinide Calcium. The MFDS reviews the Mitiglinide Calcium KDMF as part of the drug registration process and uses the information provided in the Mitiglinide Calcium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mitiglinide Calcium 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 Mitiglinide Calcium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mitiglinide Calcium suppliers with KDMF on PharmaCompass.
Mitiglinide Calcium 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 Mitiglinide Calcium 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 Mitiglinide Calcium GMP manufacturer or Mitiglinide Calcium GMP API supplier for your needs.
A Mitiglinide Calcium CoA (Certificate of Analysis) is a formal document that attests to Mitiglinide Calcium's compliance with Mitiglinide Calcium specifications and serves as a tool for batch-level quality control.
Mitiglinide Calcium CoA mostly includes findings from lab analyses of a specific batch. For each Mitiglinide Calcium 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.
Mitiglinide Calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (Mitiglinide Calcium EP), Mitiglinide Calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mitiglinide Calcium USP).
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