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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
AMI Lifesciences is Driven by Chemistry. Powered by People.
CEP/COS 
EU-WC
NDC
KDMF
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
AMI Lifesciences is Driven by Chemistry. Powered by People.
AMI Lifesciences is Driven by Chemistry. Powered by People.
AMI Lifesciences is Driven by Chemistry. Powered by People.
AMI Lifesciences is Driven by Chemistry. Powered by People.
AMI Lifesciences is Driven by Chemistry. Powered by People.
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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 : 38766
Submission : 2023-09-15
Status :
Type : II
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AMI Lifesciences is Driven by Chemistry. Powered by People.
Certificate Number : CEP 2015-173 - Rev 03
Status : Valid
Issue Date : 2024-12-03
Type : Chemical
Substance Number : 2409
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AMI Lifesciences is Driven by Chemistry. Powered by People.
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal-Padra, City Karakhadi -39145...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2021-11-10
Registration Number : 20180515-209-J-27(5)
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block NO. 82/B, ECP Road, AT&Post : Karakhadi-391 450, Taluka:Padra, Dist. Vadodara, ...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2019-07-24
Registration Number : 20180515-209-J-27(3)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Gapi Bio Co., Ltd.
Registration Date : 2018-08-27
Registration Number : 20180515-209-J-27(2)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No.82/B, ECP Road, At & Post, Karakhadi, TAL-Pradra City : Karakhadi-391 450, D...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-08-14
Registration Number : 20180515-209-J-27(1)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No.82/B, ECP Road, At & Post, Karakhadi, TAL-Pradra City : Karakhadi-391 450, D...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2018-05-15
Registration Number : 20180515-209-J-27
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No.82/B, ECP Road, At & Post, Karakhadi, TAL-Pradra City : Karakhadi-391 450, D...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Huseeed Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20180515-209-J-27(6)
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road, At & Post. Karakhadi-391 450, Taluka:Padra, Dist.Vadodara, ...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Myungmoon Pharmaceutical Co., Ltd.
Registration Date : 2019-09-24
Registration Number : 20180515-209-J-27(4)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
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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, ...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
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 ...
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...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...
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API Imports and Exports
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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Diacerein
Dosage Form : Capsule
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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NEWS #PharmaBuzz
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Diacerein 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 Diacerein manufacturer or Diacerein supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Diacerein manufacturer or Diacerein supplier.
PharmaCompass also assists you with knowing the Diacerein API Price utilized in the formulation of products. Diacerein API Price is not always fixed or binding as the Diacerein Price is obtained through a variety of data sources. The Diacerein Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DIACERIN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DIACERIN, including repackagers and relabelers. The FDA regulates DIACERIN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DIACERIN 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 DIACERIN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DIACERIN supplier is an individual or a company that provides DIACERIN active pharmaceutical ingredient (API) or DIACERIN finished formulations upon request. The DIACERIN suppliers may include DIACERIN API manufacturers, exporters, distributors and traders.
click here to find a list of DIACERIN suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DIACERIN DMF (Drug Master File) is a document detailing the whole manufacturing process of DIACERIN active pharmaceutical ingredient (API) in detail. Different forms of DIACERIN DMFs exist exist since differing nations have different regulations, such as DIACERIN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DIACERIN DMF submitted to regulatory agencies in the US is known as a USDMF. DIACERIN USDMF includes data on DIACERIN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DIACERIN USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DIACERIN 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 DIACERIN Drug Master File in Korea (DIACERIN KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DIACERIN. The MFDS reviews the DIACERIN KDMF as part of the drug registration process and uses the information provided in the DIACERIN KDMF to evaluate the safety and efficacy of the drug.
After submitting a DIACERIN 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 DIACERIN API can apply through the Korea Drug Master File (KDMF).
click here to find a list of DIACERIN suppliers with KDMF on PharmaCompass.
A DIACERIN CEP of the European Pharmacopoeia monograph is often referred to as a DIACERIN Certificate of Suitability (COS). The purpose of a DIACERIN CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DIACERIN EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DIACERIN to their clients by showing that a DIACERIN CEP has been issued for it. The manufacturer submits a DIACERIN CEP (COS) as part of the market authorization procedure, and it takes on the role of a DIACERIN CEP holder for the record. Additionally, the data presented in the DIACERIN CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DIACERIN DMF.
A DIACERIN CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DIACERIN CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of DIACERIN suppliers with CEP (COS) on PharmaCompass.
A DIACERIN written confirmation (DIACERIN WC) is an official document issued by a regulatory agency to a DIACERIN manufacturer, verifying that the manufacturing facility of a DIACERIN active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DIACERIN APIs or DIACERIN finished pharmaceutical products to another nation, regulatory agencies frequently require a DIACERIN WC (written confirmation) as part of the regulatory process.
click here to find a list of DIACERIN 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 DIACERIN as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DIACERIN 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 DIACERIN 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 DIACERIN and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DIACERIN NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DIACERIN suppliers with NDC on PharmaCompass.
DIACERIN 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 DIACERIN 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 DIACERIN GMP manufacturer or DIACERIN GMP API supplier for your needs.
A DIACERIN CoA (Certificate of Analysis) is a formal document that attests to DIACERIN's compliance with DIACERIN specifications and serves as a tool for batch-level quality control.
DIACERIN CoA mostly includes findings from lab analyses of a specific batch. For each DIACERIN 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.
DIACERIN may be tested according to a variety of international standards, such as European Pharmacopoeia (DIACERIN EP), DIACERIN JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DIACERIN USP).
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