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API SUPPLIERS
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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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34357
Submission : 2019-12-10
Status :
Type : II
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 : 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
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
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ABOUT THIS PAGE
38
PharmaCompass offers a list of Sucroferric Oxyhydroxide 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 Sucroferric Oxyhydroxide manufacturer or Sucroferric Oxyhydroxide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sucroferric Oxyhydroxide manufacturer or Sucroferric Oxyhydroxide supplier.
PharmaCompass also assists you with knowing the Sucroferric Oxyhydroxide API Price utilized in the formulation of products. Sucroferric Oxyhydroxide API Price is not always fixed or binding as the Sucroferric Oxyhydroxide Price is obtained through a variety of data sources. The Sucroferric Oxyhydroxide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ferosoft S manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferosoft S, including repackagers and relabelers. The FDA regulates Ferosoft S manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferosoft S 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 Ferosoft S manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ferosoft S supplier is an individual or a company that provides Ferosoft S active pharmaceutical ingredient (API) or Ferosoft S finished formulations upon request. The Ferosoft S suppliers may include Ferosoft S API manufacturers, exporters, distributors and traders.
click here to find a list of Ferosoft S suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ferosoft S DMF (Drug Master File) is a document detailing the whole manufacturing process of Ferosoft S active pharmaceutical ingredient (API) in detail. Different forms of Ferosoft S DMFs exist exist since differing nations have different regulations, such as Ferosoft S USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ferosoft S DMF submitted to regulatory agencies in the US is known as a USDMF. Ferosoft S USDMF includes data on Ferosoft S's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ferosoft S USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ferosoft S 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 Ferosoft S Drug Master File in Korea (Ferosoft S KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ferosoft S. The MFDS reviews the Ferosoft S KDMF as part of the drug registration process and uses the information provided in the Ferosoft S KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ferosoft S 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 Ferosoft S API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ferosoft S suppliers with KDMF on PharmaCompass.
A Ferosoft S written confirmation (Ferosoft S WC) is an official document issued by a regulatory agency to a Ferosoft S manufacturer, verifying that the manufacturing facility of a Ferosoft S active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ferosoft S APIs or Ferosoft S finished pharmaceutical products to another nation, regulatory agencies frequently require a Ferosoft S WC (written confirmation) as part of the regulatory process.
click here to find a list of Ferosoft S 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 Ferosoft S as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ferosoft S 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 Ferosoft S 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 Ferosoft S and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ferosoft S NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ferosoft S suppliers with NDC on PharmaCompass.
Ferosoft S 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 Ferosoft S 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 Ferosoft S GMP manufacturer or Ferosoft S GMP API supplier for your needs.
A Ferosoft S CoA (Certificate of Analysis) is a formal document that attests to Ferosoft S's compliance with Ferosoft S specifications and serves as a tool for batch-level quality control.
Ferosoft S CoA mostly includes findings from lab analyses of a specific batch. For each Ferosoft S 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.
Ferosoft S may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferosoft S EP), Ferosoft S JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferosoft S USP).
