Synopsis
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CEP/COS
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NDC API
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VMF
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EDQM
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USP
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JP
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Others
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FDA Orange Book
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Reliable Spanish CDMO Delivering High-Quality APIs and Intermediates with Excellence, Flexibility, and Regulatory Compliance.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Together we can improve the quality of life
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
AMI Lifesciences is Driven by Chemistry. Powered by People.
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USDMF
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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...
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 : Huseeed Co., Ltd.
Registration Date : 2022-07-26
Registration Number : 20210323-211-J-662(6)
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 : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2022-01-12
Registration Number : 20210323-211-J-662(4)
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 : Agerson Bio Co., Ltd.
Registration Date : 2025-02-05
Registration Number : 20210323-211-J-662(9)
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 : Farm East Co., Ltd.
Registration Date : 2023-10-06
Registration Number : 20210323-211-J-662(8)
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 : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2021-09-09
Registration Number : 20210323-211-J-662(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 : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-09-07
Registration Number : 20210323-211-J-662(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 : Hwain Farm Co., Ltd.
Registration Date : 2022-05-12
Registration Number : 20210323-211-J-662(5)
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 : IMCD Korea Co., Ltd.
Registration Date : 2021-08-30
Registration Number : 20210323-211-J-662(1)
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 : Hiple Co., Ltd.
Registration Date : 2023-09-12
Registration Number : 20210323-211-J-662(7)
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 : Aging Life Science Co., Ltd.
Registration Date : 2021-03-23
Registration Number : 20210323-211-J-662
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]Listed Suppliers
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...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
About the Company : Chynops Pharma, a company certified with ISO 9001:2015, is situated in Ahmedabad, India. We specialize in exporting, supplying, and trading a wide range of products, including APIs...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Reliable Spanish CDMO Delivering High-Quality APIs and Intermediates with Excellence, Flexibility, and Regulatory Compliance.
About the Company : Kinsy, an independent CDMO in Spain, offers over 30 years of expertise in developing and manufacturing advanced pharmaceutical intermediates and APIs. We provide innovative route d...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal MediPharma is a Star One Export House with over two decades of experience serving customers across 50+ countries. The company specializes in sourcing and exporting APIs for hu...
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...
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
About the Company : Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, offering a strong India advantage to glob...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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NEWS #PharmaBuzz
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ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
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PharmaCompass offers a list of Benfotiamine 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 Benfotiamine manufacturer or Benfotiamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benfotiamine manufacturer or Benfotiamine supplier.
PharmaCompass also assists you with knowing the Benfotiamine API Price utilized in the formulation of products. Benfotiamine API Price is not always fixed or binding as the Benfotiamine Price is obtained through a variety of data sources. The Benfotiamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Benfotiamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benfotiamine, including repackagers and relabelers. The FDA regulates Benfotiamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benfotiamine 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 Benfotiamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benfotiamine supplier is an individual or a company that provides Benfotiamine active pharmaceutical ingredient (API) or Benfotiamine finished formulations upon request. The Benfotiamine suppliers may include Benfotiamine API manufacturers, exporters, distributors and traders.
click here to find a list of Benfotiamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benfotiamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Benfotiamine active pharmaceutical ingredient (API) in detail. Different forms of Benfotiamine DMFs exist exist since differing nations have different regulations, such as Benfotiamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benfotiamine DMF submitted to regulatory agencies in the US is known as a USDMF. Benfotiamine USDMF includes data on Benfotiamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benfotiamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benfotiamine suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Benfotiamine Drug Master File in Japan (Benfotiamine JDMF) empowers Benfotiamine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Benfotiamine JDMF during the approval evaluation for pharmaceutical products. At the time of Benfotiamine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Benfotiamine suppliers with JDMF 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 Benfotiamine Drug Master File in Korea (Benfotiamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Benfotiamine. The MFDS reviews the Benfotiamine KDMF as part of the drug registration process and uses the information provided in the Benfotiamine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Benfotiamine 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 Benfotiamine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Benfotiamine suppliers with KDMF on PharmaCompass.
A Benfotiamine written confirmation (Benfotiamine WC) is an official document issued by a regulatory agency to a Benfotiamine manufacturer, verifying that the manufacturing facility of a Benfotiamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benfotiamine APIs or Benfotiamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Benfotiamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Benfotiamine suppliers with Written Confirmation (WC) on PharmaCompass.
Benfotiamine 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 Benfotiamine 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 Benfotiamine GMP manufacturer or Benfotiamine GMP API supplier for your needs.
A Benfotiamine CoA (Certificate of Analysis) is a formal document that attests to Benfotiamine's compliance with Benfotiamine specifications and serves as a tool for batch-level quality control.
Benfotiamine CoA mostly includes findings from lab analyses of a specific batch. For each Benfotiamine 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.
Benfotiamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Benfotiamine EP), Benfotiamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benfotiamine USP).
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