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Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
About the Company : Lupin Manufacturing Solutions (LMS), a wholly owned Lupin subsidiary, offers high-quality APIs and end-to-end CDMO services from R&D to commercial scale. Backed by five decades of ...
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
About the Company : SNJ Labs, established in 2013, is India’s largest manufacturer of Iron Sucrose, achieving a production capacity of 120 MT per year within five years. The company specializes in A...
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
About the Company : SNJ Labs, established in 2013, is India’s largest manufacturer of Iron Sucrose, achieving a production capacity of 120 MT per year within five years. The company specializes in A...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
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...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
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...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
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 legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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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, 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.
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, and COA 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, and COA 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, 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).
