Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Australia
DRUG PRODUCT COMPOSITIONS
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
AMI Lifesciences is Driven by Chemistry. Powered by People.
EU-WC
KDMF
CN
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
Together we can improve the quality of life
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37981
Submission : 2023-01-25
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
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, ...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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 ...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with over 26 years of expertise in human and veterinary pharmaceuticals. Operating in 40+ countries, we own two st...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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]Related Excipient Companies
Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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]Pharm-RX Chemical
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]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Lubricants & Glidants
Excipient Details : Lubristar is used as a lubricant in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, PSD, DMF, ...
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Sucrex (Sucralose) is used as a sweetener and a taste masking agent in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : NA
Ingredient(s) : Sucralose
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]Shanghai Minbiotech
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]Alcedo Pharmachem
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]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
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
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]Keval Exports
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]Nitika Pharmaceutical Specialities
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]Silverline Chemicals
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]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Fillers, Diluents & Binders
Direct Compression
Thickeners and Stabilizers
Controlled & Modified Release
Disintegrants & Superdisintegrants
Chewable & Orodispersible Aids
Granulation
Taste Masking
Lubricants & Glidants
Co-Processed Excipients
Film Formers & Plasticizers
Parenteral
Solubilizers
Topical
Rheology Modifiers
API Stability Enhancers
Empty Capsules
Coloring Agents
Emulsifying Agents
Vegetarian Capsules
Digital Content
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
64
PharmaCompass offers a list of Sevelamer Carbonate 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 Sevelamer Carbonate manufacturer or Sevelamer Carbonate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sevelamer Carbonate manufacturer or Sevelamer Carbonate supplier.
PharmaCompass also assists you with knowing the Sevelamer Carbonate API Price utilized in the formulation of products. Sevelamer Carbonate API Price is not always fixed or binding as the Sevelamer Carbonate Price is obtained through a variety of data sources. The Sevelamer Carbonate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sevelamer Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sevelamer Carbonate, including repackagers and relabelers. The FDA regulates Sevelamer Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sevelamer Carbonate 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 Sevelamer Carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sevelamer Carbonate supplier is an individual or a company that provides Sevelamer Carbonate active pharmaceutical ingredient (API) or Sevelamer Carbonate finished formulations upon request. The Sevelamer Carbonate suppliers may include Sevelamer Carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Sevelamer Carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sevelamer Carbonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sevelamer Carbonate active pharmaceutical ingredient (API) in detail. Different forms of Sevelamer Carbonate DMFs exist exist since differing nations have different regulations, such as Sevelamer Carbonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sevelamer Carbonate DMF submitted to regulatory agencies in the US is known as a USDMF. Sevelamer Carbonate USDMF includes data on Sevelamer Carbonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sevelamer Carbonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sevelamer Carbonate 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 Sevelamer Carbonate Drug Master File in Korea (Sevelamer Carbonate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sevelamer Carbonate. The MFDS reviews the Sevelamer Carbonate KDMF as part of the drug registration process and uses the information provided in the Sevelamer Carbonate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sevelamer Carbonate 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 Sevelamer Carbonate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sevelamer Carbonate suppliers with KDMF on PharmaCompass.
A Sevelamer Carbonate written confirmation (Sevelamer Carbonate WC) is an official document issued by a regulatory agency to a Sevelamer Carbonate manufacturer, verifying that the manufacturing facility of a Sevelamer Carbonate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sevelamer Carbonate APIs or Sevelamer Carbonate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sevelamer Carbonate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sevelamer Carbonate 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 Sevelamer Carbonate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sevelamer Carbonate 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 Sevelamer Carbonate 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 Sevelamer Carbonate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sevelamer Carbonate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sevelamer Carbonate suppliers with NDC on PharmaCompass.
Sevelamer Carbonate 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 Sevelamer Carbonate 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 Sevelamer Carbonate GMP manufacturer or Sevelamer Carbonate GMP API supplier for your needs.
A Sevelamer Carbonate CoA (Certificate of Analysis) is a formal document that attests to Sevelamer Carbonate's compliance with Sevelamer Carbonate specifications and serves as a tool for batch-level quality control.
Sevelamer Carbonate CoA mostly includes findings from lab analyses of a specific batch. For each Sevelamer Carbonate 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.
Sevelamer Carbonate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sevelamer Carbonate EP), Sevelamer Carbonate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sevelamer Carbonate USP).
