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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-04
Pay. Date : 2016-07-14
DMF Number : 28865
Submission : 2016-07-07
Status :
Type : II
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34357
Submission : 2019-12-10
Status :
Type : II
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30380
Submission : 2016-01-03
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-10
Pay. Date : 2023-09-28
DMF Number : 38610
Submission : 2023-07-31
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34957
Submission : 2020-06-30
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33643
Submission : 2019-03-30
Status :
Type : II
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ABOUT THIS PAGE
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PharmaCompass offers a list of Iron Sucrose API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Iron Sucrose manufacturer or Iron Sucrose supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Iron Sucrose manufacturer or Iron Sucrose supplier.
PharmaCompass also assists you with knowing the Iron Sucrose API Price utilized in the formulation of products. Iron Sucrose API Price is not always fixed or binding as the Iron Sucrose Price is obtained through a variety of data sources. The Iron Sucrose Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ferric oxyhydroxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferric oxyhydroxide, including repackagers and relabelers. The FDA regulates Ferric oxyhydroxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferric oxyhydroxide 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 Ferric oxyhydroxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ferric oxyhydroxide supplier is an individual or a company that provides Ferric oxyhydroxide active pharmaceutical ingredient (API) or Ferric oxyhydroxide finished formulations upon request. The Ferric oxyhydroxide suppliers may include Ferric oxyhydroxide API manufacturers, exporters, distributors and traders.
click here to find a list of Ferric oxyhydroxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ferric oxyhydroxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Ferric oxyhydroxide active pharmaceutical ingredient (API) in detail. Different forms of Ferric oxyhydroxide DMFs exist exist since differing nations have different regulations, such as Ferric oxyhydroxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ferric oxyhydroxide DMF submitted to regulatory agencies in the US is known as a USDMF. Ferric oxyhydroxide USDMF includes data on Ferric oxyhydroxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ferric oxyhydroxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ferric oxyhydroxide 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 Ferric oxyhydroxide Drug Master File in Korea (Ferric oxyhydroxide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ferric oxyhydroxide. The MFDS reviews the Ferric oxyhydroxide KDMF as part of the drug registration process and uses the information provided in the Ferric oxyhydroxide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ferric oxyhydroxide 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 Ferric oxyhydroxide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ferric oxyhydroxide suppliers with KDMF on PharmaCompass.
A Ferric oxyhydroxide written confirmation (Ferric oxyhydroxide WC) is an official document issued by a regulatory agency to a Ferric oxyhydroxide manufacturer, verifying that the manufacturing facility of a Ferric oxyhydroxide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ferric oxyhydroxide APIs or Ferric oxyhydroxide finished pharmaceutical products to another nation, regulatory agencies frequently require a Ferric oxyhydroxide WC (written confirmation) as part of the regulatory process.
click here to find a list of Ferric oxyhydroxide 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 Ferric oxyhydroxide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ferric oxyhydroxide 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 Ferric oxyhydroxide 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 Ferric oxyhydroxide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ferric oxyhydroxide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ferric oxyhydroxide suppliers with NDC on PharmaCompass.
Ferric oxyhydroxide 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 Ferric oxyhydroxide 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 Ferric oxyhydroxide GMP manufacturer or Ferric oxyhydroxide GMP API supplier for your needs.
A Ferric oxyhydroxide CoA (Certificate of Analysis) is a formal document that attests to Ferric oxyhydroxide's compliance with Ferric oxyhydroxide specifications and serves as a tool for batch-level quality control.
Ferric oxyhydroxide CoA mostly includes findings from lab analyses of a specific batch. For each Ferric oxyhydroxide 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.
Ferric oxyhydroxide may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferric oxyhydroxide EP), Ferric oxyhydroxide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferric oxyhydroxide USP).
