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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.
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
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.
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
EU-WC
NDC
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
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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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...
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
About the Company : SNJ Labs Pvt. Ltd., established in 2013, has rapidly emerged as India’s largest manufacturer of Iron Sucrose, achieving a production capacity of 120 MT per year within just five ...
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 ...
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
About the Company : Pharmathen, established in 1969, has emerged as a leading in-house development partner in Europe. It specializes in the development, registration, manufacturing & life-cycle manage...
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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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 VENOFER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of VENOFER, including repackagers and relabelers. The FDA regulates VENOFER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. VENOFER 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 VENOFER manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A VENOFER supplier is an individual or a company that provides VENOFER active pharmaceutical ingredient (API) or VENOFER finished formulations upon request. The VENOFER suppliers may include VENOFER API manufacturers, exporters, distributors and traders.
click here to find a list of VENOFER suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A VENOFER DMF (Drug Master File) is a document detailing the whole manufacturing process of VENOFER active pharmaceutical ingredient (API) in detail. Different forms of VENOFER DMFs exist exist since differing nations have different regulations, such as VENOFER USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A VENOFER DMF submitted to regulatory agencies in the US is known as a USDMF. VENOFER USDMF includes data on VENOFER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The VENOFER USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of VENOFER 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 VENOFER Drug Master File in Korea (VENOFER KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of VENOFER. The MFDS reviews the VENOFER KDMF as part of the drug registration process and uses the information provided in the VENOFER KDMF to evaluate the safety and efficacy of the drug.
After submitting a VENOFER 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 VENOFER API can apply through the Korea Drug Master File (KDMF).
click here to find a list of VENOFER suppliers with KDMF on PharmaCompass.
A VENOFER written confirmation (VENOFER WC) is an official document issued by a regulatory agency to a VENOFER manufacturer, verifying that the manufacturing facility of a VENOFER active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting VENOFER APIs or VENOFER finished pharmaceutical products to another nation, regulatory agencies frequently require a VENOFER WC (written confirmation) as part of the regulatory process.
click here to find a list of VENOFER 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 VENOFER as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for VENOFER 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 VENOFER 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 VENOFER and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a VENOFER NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of VENOFER suppliers with NDC on PharmaCompass.
VENOFER 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 VENOFER 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 VENOFER GMP manufacturer or VENOFER GMP API supplier for your needs.
A VENOFER CoA (Certificate of Analysis) is a formal document that attests to VENOFER's compliance with VENOFER specifications and serves as a tool for batch-level quality control.
VENOFER CoA mostly includes findings from lab analyses of a specific batch. For each VENOFER 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.
VENOFER may be tested according to a variety of international standards, such as European Pharmacopoeia (VENOFER EP), VENOFER JP (Japanese Pharmacopeia) and the US Pharmacopoeia (VENOFER USP).
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