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API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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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
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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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
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, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/2.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Injection For Intraven...
Dosage Strength : 50MG/2.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Injection For Intraven...
Dosage Strength : 100MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Injection For Intraven...
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
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ABOUT THIS PAGE
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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 Sucroferric Oxyhydroxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sucroferric Oxyhydroxide, including repackagers and relabelers. The FDA regulates Sucroferric Oxyhydroxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sucroferric 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 Sucroferric Oxyhydroxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sucroferric Oxyhydroxide supplier is an individual or a company that provides Sucroferric Oxyhydroxide active pharmaceutical ingredient (API) or Sucroferric Oxyhydroxide finished formulations upon request. The Sucroferric Oxyhydroxide suppliers may include Sucroferric Oxyhydroxide API manufacturers, exporters, distributors and traders.
click here to find a list of Sucroferric Oxyhydroxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sucroferric Oxyhydroxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Sucroferric Oxyhydroxide active pharmaceutical ingredient (API) in detail. Different forms of Sucroferric Oxyhydroxide DMFs exist exist since differing nations have different regulations, such as Sucroferric Oxyhydroxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sucroferric Oxyhydroxide DMF submitted to regulatory agencies in the US is known as a USDMF. Sucroferric Oxyhydroxide USDMF includes data on Sucroferric Oxyhydroxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sucroferric Oxyhydroxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sucroferric 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 Sucroferric Oxyhydroxide Drug Master File in Korea (Sucroferric Oxyhydroxide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sucroferric Oxyhydroxide. The MFDS reviews the Sucroferric Oxyhydroxide KDMF as part of the drug registration process and uses the information provided in the Sucroferric Oxyhydroxide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sucroferric 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 Sucroferric Oxyhydroxide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sucroferric Oxyhydroxide suppliers with KDMF on PharmaCompass.
A Sucroferric Oxyhydroxide written confirmation (Sucroferric Oxyhydroxide WC) is an official document issued by a regulatory agency to a Sucroferric Oxyhydroxide manufacturer, verifying that the manufacturing facility of a Sucroferric Oxyhydroxide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sucroferric Oxyhydroxide APIs or Sucroferric Oxyhydroxide finished pharmaceutical products to another nation, regulatory agencies frequently require a Sucroferric Oxyhydroxide WC (written confirmation) as part of the regulatory process.
click here to find a list of Sucroferric 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 Sucroferric Oxyhydroxide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sucroferric 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 Sucroferric 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 Sucroferric Oxyhydroxide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sucroferric Oxyhydroxide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sucroferric Oxyhydroxide suppliers with NDC on PharmaCompass.
Sucroferric 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 Sucroferric 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 Sucroferric Oxyhydroxide GMP manufacturer or Sucroferric Oxyhydroxide GMP API supplier for your needs.
A Sucroferric Oxyhydroxide CoA (Certificate of Analysis) is a formal document that attests to Sucroferric Oxyhydroxide's compliance with Sucroferric Oxyhydroxide specifications and serves as a tool for batch-level quality control.
Sucroferric Oxyhydroxide CoA mostly includes findings from lab analyses of a specific batch. For each Sucroferric 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.
Sucroferric Oxyhydroxide may be tested according to a variety of international standards, such as European Pharmacopoeia (Sucroferric Oxyhydroxide EP), Sucroferric Oxyhydroxide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sucroferric Oxyhydroxide USP).
