Synopsis
0
CEP/COS
0
JDMF
0
VMF
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Click Us!
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.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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 : 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
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm : CTO-SEZ-Process Unit-01, Sector No 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey...
TAPI offers customized CDMO Solutions for API development and manufacturing services.
Date of Issue : 2022-05-27
Valid Till : 2025-05-20
Written Confirmation Number : WC-0001A2
Address of the Firm : Q-1-4,Industrial area ,Ghinrongi Malanpur -477 117, Dist -Bhind (MP)
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seqens
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Fillers, Diluents & Binders
Controlled & Modified Release
Thickeners and Stabilizers
Direct Compression
Disintegrants & Superdisintegrants
Solubilizers
Granulation
Lubricants & Glidants
Taste Masking
Topical
Parenteral
Film Formers & Plasticizers
Co-Processed Excipients
Empty Capsules
Emulsifying Agents
Chewable & Orodispersible Aids
API Stability Enhancers
Coloring Agents
Rheology Modifiers
Vegetarian Capsules
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
ABOUT THIS PAGE
A Iron Sucrose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iron Sucrose, including repackagers and relabelers. The FDA regulates Iron Sucrose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iron Sucrose 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 Iron Sucrose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iron Sucrose supplier is an individual or a company that provides Iron Sucrose active pharmaceutical ingredient (API) or Iron Sucrose finished formulations upon request. The Iron Sucrose suppliers may include Iron Sucrose API manufacturers, exporters, distributors and traders.
click here to find a list of Iron Sucrose suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iron Sucrose DMF (Drug Master File) is a document detailing the whole manufacturing process of Iron Sucrose active pharmaceutical ingredient (API) in detail. Different forms of Iron Sucrose DMFs exist exist since differing nations have different regulations, such as Iron Sucrose USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iron Sucrose DMF submitted to regulatory agencies in the US is known as a USDMF. Iron Sucrose USDMF includes data on Iron Sucrose's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iron Sucrose USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iron Sucrose 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 Iron Sucrose Drug Master File in Korea (Iron Sucrose KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Iron Sucrose. The MFDS reviews the Iron Sucrose KDMF as part of the drug registration process and uses the information provided in the Iron Sucrose KDMF to evaluate the safety and efficacy of the drug.
After submitting a Iron Sucrose 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 Iron Sucrose API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Iron Sucrose suppliers with KDMF on PharmaCompass.
A Iron Sucrose written confirmation (Iron Sucrose WC) is an official document issued by a regulatory agency to a Iron Sucrose manufacturer, verifying that the manufacturing facility of a Iron Sucrose active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Iron Sucrose APIs or Iron Sucrose finished pharmaceutical products to another nation, regulatory agencies frequently require a Iron Sucrose WC (written confirmation) as part of the regulatory process.
click here to find a list of Iron Sucrose 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 Iron Sucrose as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Iron Sucrose 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 Iron Sucrose 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 Iron Sucrose and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Iron Sucrose NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Iron Sucrose suppliers with NDC on PharmaCompass.
Iron Sucrose 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 Iron Sucrose 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 Iron Sucrose GMP manufacturer or Iron Sucrose GMP API supplier for your needs.
A Iron Sucrose CoA (Certificate of Analysis) is a formal document that attests to Iron Sucrose's compliance with Iron Sucrose specifications and serves as a tool for batch-level quality control.
Iron Sucrose CoA mostly includes findings from lab analyses of a specific batch. For each Iron Sucrose 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.
Iron Sucrose may be tested according to a variety of international standards, such as European Pharmacopoeia (Iron Sucrose EP), Iron Sucrose JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Iron Sucrose USP).
LOOKING FOR A SUPPLIER?
