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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.
HRV Pharma - 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
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
EU-WC
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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
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-08
Pay. Date : 2012-11-26
DMF Number : 22293
Submission : 2008-12-09
Status :
Type : II
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Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
Date of Issue : 2025-10-07
Valid Till : 2028-10-06
Written Confirmation Number : WC-0293
Address of the Firm : 103-106, GIDC Halol, Dist.-Panchmahal, Pin-389350, Gujarat, India
AMI Lifesciences is Driven by Chemistry. Powered by People.
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post Karakhadi, Tal - Padra, Dist. Baroda, Gujara...
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
Date of Issue : 2025-08-05
Valid Till : 2028-06-16
Written Confirmation Number : WC-0049
Address of the Firm : Block -21, At & Post. -Dabhasa, Tal. -Padra, Dist. -Vadodara -391 440, Gujarat, ...
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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 RENVELA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of RENVELA, including repackagers and relabelers. The FDA regulates RENVELA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. RENVELA 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 RENVELA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A RENVELA supplier is an individual or a company that provides RENVELA active pharmaceutical ingredient (API) or RENVELA finished formulations upon request. The RENVELA suppliers may include RENVELA API manufacturers, exporters, distributors and traders.
click here to find a list of RENVELA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A RENVELA DMF (Drug Master File) is a document detailing the whole manufacturing process of RENVELA active pharmaceutical ingredient (API) in detail. Different forms of RENVELA DMFs exist exist since differing nations have different regulations, such as RENVELA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A RENVELA DMF submitted to regulatory agencies in the US is known as a USDMF. RENVELA USDMF includes data on RENVELA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The RENVELA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of RENVELA 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 RENVELA Drug Master File in Korea (RENVELA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of RENVELA. The MFDS reviews the RENVELA KDMF as part of the drug registration process and uses the information provided in the RENVELA KDMF to evaluate the safety and efficacy of the drug.
After submitting a RENVELA 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 RENVELA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of RENVELA suppliers with KDMF on PharmaCompass.
A RENVELA written confirmation (RENVELA WC) is an official document issued by a regulatory agency to a RENVELA manufacturer, verifying that the manufacturing facility of a RENVELA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting RENVELA APIs or RENVELA finished pharmaceutical products to another nation, regulatory agencies frequently require a RENVELA WC (written confirmation) as part of the regulatory process.
click here to find a list of RENVELA 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 RENVELA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for RENVELA 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 RENVELA 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 RENVELA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a RENVELA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of RENVELA suppliers with NDC on PharmaCompass.
RENVELA 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 RENVELA 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 RENVELA GMP manufacturer or RENVELA GMP API supplier for your needs.
A RENVELA CoA (Certificate of Analysis) is a formal document that attests to RENVELA's compliance with RENVELA specifications and serves as a tool for batch-level quality control.
RENVELA CoA mostly includes findings from lab analyses of a specific batch. For each RENVELA 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.
RENVELA may be tested according to a variety of international standards, such as European Pharmacopoeia (RENVELA EP), RENVELA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (RENVELA USP).
