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API SUPPLIERS
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
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Drugs in Development
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DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19815
DOSAGE - TABLET;ORAL - 2.5MG **Federal Regist...DOSAGE - TABLET;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19815
DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19815
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Midodrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Midodrine, including repackagers and relabelers. The FDA regulates Midodrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Midodrine 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 Midodrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Midodrine supplier is an individual or a company that provides Midodrine active pharmaceutical ingredient (API) or Midodrine finished formulations upon request. The Midodrine suppliers may include Midodrine API manufacturers, exporters, distributors and traders.
click here to find a list of Midodrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Midodrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Midodrine active pharmaceutical ingredient (API) in detail. Different forms of Midodrine DMFs exist exist since differing nations have different regulations, such as Midodrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Midodrine DMF submitted to regulatory agencies in the US is known as a USDMF. Midodrine USDMF includes data on Midodrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Midodrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Midodrine 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 Midodrine Drug Master File in Japan (Midodrine JDMF) empowers Midodrine 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 Midodrine JDMF during the approval evaluation for pharmaceutical products. At the time of Midodrine 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 Midodrine suppliers with JDMF on PharmaCompass.
A Midodrine written confirmation (Midodrine WC) is an official document issued by a regulatory agency to a Midodrine manufacturer, verifying that the manufacturing facility of a Midodrine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Midodrine APIs or Midodrine finished pharmaceutical products to another nation, regulatory agencies frequently require a Midodrine WC (written confirmation) as part of the regulatory process.
click here to find a list of Midodrine suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Midodrine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Midodrine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Midodrine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Midodrine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Midodrine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Midodrine suppliers with NDC on PharmaCompass.
Midodrine 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 Midodrine 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 Midodrine GMP manufacturer or Midodrine GMP API supplier for your needs.
A Midodrine CoA (Certificate of Analysis) is a formal document that attests to Midodrine's compliance with Midodrine specifications and serves as a tool for batch-level quality control.
Midodrine CoA mostly includes findings from lab analyses of a specific batch. For each Midodrine 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.
Midodrine may be tested according to a variety of international standards, such as European Pharmacopoeia (Midodrine EP), Midodrine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Midodrine USP).
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