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API SUPPLIERS
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USDMF
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27005
Submission : 2013-03-02
Status :
Type : II
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
About the Company : Vital Laboratories is an API and intermediates manufacturer established in 1998, beginning with quinine derivatives. Today, it is a global leader in quinine and hyoscine derivative...
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DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
USFDA APPLICATION NUMBER - 18920
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
USFDA APPLICATION NUMBER - 21625
DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006...DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
USFDA APPLICATION NUMBER - 8809
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PharmaCompass offers a list of Riboflavin 5 Phosphate Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Riboflavin 5 Phosphate Sodium manufacturer or Riboflavin 5 Phosphate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Riboflavin 5 Phosphate Sodium manufacturer or Riboflavin 5 Phosphate Sodium supplier.
A Riboflavin (phosphate sodium) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Riboflavin (phosphate sodium), including repackagers and relabelers. The FDA regulates Riboflavin (phosphate sodium) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Riboflavin (phosphate sodium) 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 Riboflavin (phosphate sodium) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Riboflavin (phosphate sodium) supplier is an individual or a company that provides Riboflavin (phosphate sodium) active pharmaceutical ingredient (API) or Riboflavin (phosphate sodium) finished formulations upon request. The Riboflavin (phosphate sodium) suppliers may include Riboflavin (phosphate sodium) API manufacturers, exporters, distributors and traders.
click here to find a list of Riboflavin (phosphate sodium) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Riboflavin (phosphate sodium) DMF (Drug Master File) is a document detailing the whole manufacturing process of Riboflavin (phosphate sodium) active pharmaceutical ingredient (API) in detail. Different forms of Riboflavin (phosphate sodium) DMFs exist exist since differing nations have different regulations, such as Riboflavin (phosphate sodium) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Riboflavin (phosphate sodium) DMF submitted to regulatory agencies in the US is known as a USDMF. Riboflavin (phosphate sodium) USDMF includes data on Riboflavin (phosphate sodium)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Riboflavin (phosphate sodium) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Riboflavin (phosphate sodium) 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 Riboflavin (phosphate sodium) Drug Master File in Japan (Riboflavin (phosphate sodium) JDMF) empowers Riboflavin (phosphate sodium) 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 Riboflavin (phosphate sodium) JDMF during the approval evaluation for pharmaceutical products. At the time of Riboflavin (phosphate sodium) 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 Riboflavin (phosphate sodium) suppliers with JDMF on PharmaCompass.
A Riboflavin (phosphate sodium) CEP of the European Pharmacopoeia monograph is often referred to as a Riboflavin (phosphate sodium) Certificate of Suitability (COS). The purpose of a Riboflavin (phosphate sodium) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Riboflavin (phosphate sodium) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Riboflavin (phosphate sodium) to their clients by showing that a Riboflavin (phosphate sodium) CEP has been issued for it. The manufacturer submits a Riboflavin (phosphate sodium) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Riboflavin (phosphate sodium) CEP holder for the record. Additionally, the data presented in the Riboflavin (phosphate sodium) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Riboflavin (phosphate sodium) DMF.
A Riboflavin (phosphate sodium) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Riboflavin (phosphate sodium) CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Riboflavin (phosphate sodium) suppliers with CEP (COS) on PharmaCompass.
A Riboflavin (phosphate sodium) written confirmation (Riboflavin (phosphate sodium) WC) is an official document issued by a regulatory agency to a Riboflavin (phosphate sodium) manufacturer, verifying that the manufacturing facility of a Riboflavin (phosphate sodium) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Riboflavin (phosphate sodium) APIs or Riboflavin (phosphate sodium) finished pharmaceutical products to another nation, regulatory agencies frequently require a Riboflavin (phosphate sodium) WC (written confirmation) as part of the regulatory process.
click here to find a list of Riboflavin (phosphate sodium) 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 Riboflavin (phosphate sodium) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Riboflavin (phosphate sodium) 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 Riboflavin (phosphate sodium) 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 Riboflavin (phosphate sodium) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Riboflavin (phosphate sodium) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Riboflavin (phosphate sodium) suppliers with NDC on PharmaCompass.
Riboflavin (phosphate sodium) 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 Riboflavin (phosphate sodium) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Riboflavin (phosphate sodium) GMP manufacturer or Riboflavin (phosphate sodium) GMP API supplier for your needs.
A Riboflavin (phosphate sodium) CoA (Certificate of Analysis) is a formal document that attests to Riboflavin (phosphate sodium)'s compliance with Riboflavin (phosphate sodium) specifications and serves as a tool for batch-level quality control.
Riboflavin (phosphate sodium) CoA mostly includes findings from lab analyses of a specific batch. For each Riboflavin (phosphate sodium) 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.
Riboflavin (phosphate sodium) may be tested according to a variety of international standards, such as European Pharmacopoeia (Riboflavin (phosphate sodium) EP), Riboflavin (phosphate sodium) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Riboflavin (phosphate sodium) USP).
