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API SUPPLIERS
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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 : Ace Biopharm Co., Ltd.
Registration Date : 2018-10-29
Registration Number : 20181029-209-J-98
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No.82/B, ECP Road, At & Post. Karakhadi, Tal-Padra, City: Karakhadi-391 450, Di...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2022-05-03
Registration Number : 20181029-209-J-98(A)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
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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...
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
About the Company : ICE Pharma manufactures active pharmaceutical ingredients, with a core focus on Ursodeoxycholic Acid (UDCA) for the treatment of liver diseases and gallstones. The company also dev...
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Doxofylline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Doxofylline manufacturer or Doxofylline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Doxofylline manufacturer or Doxofylline supplier.
A Ansimar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ansimar, including repackagers and relabelers. The FDA regulates Ansimar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ansimar 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 Ansimar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ansimar supplier is an individual or a company that provides Ansimar active pharmaceutical ingredient (API) or Ansimar finished formulations upon request. The Ansimar suppliers may include Ansimar API manufacturers, exporters, distributors and traders.
click here to find a list of Ansimar suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ansimar DMF (Drug Master File) is a document detailing the whole manufacturing process of Ansimar active pharmaceutical ingredient (API) in detail. Different forms of Ansimar DMFs exist exist since differing nations have different regulations, such as Ansimar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ansimar DMF submitted to regulatory agencies in the US is known as a USDMF. Ansimar USDMF includes data on Ansimar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ansimar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ansimar 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 Ansimar Drug Master File in Korea (Ansimar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ansimar. The MFDS reviews the Ansimar KDMF as part of the drug registration process and uses the information provided in the Ansimar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ansimar 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 Ansimar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ansimar suppliers with KDMF on PharmaCompass.
A Ansimar written confirmation (Ansimar WC) is an official document issued by a regulatory agency to a Ansimar manufacturer, verifying that the manufacturing facility of a Ansimar active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ansimar APIs or Ansimar finished pharmaceutical products to another nation, regulatory agencies frequently require a Ansimar WC (written confirmation) as part of the regulatory process.
click here to find a list of Ansimar 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 Ansimar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ansimar 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 Ansimar 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 Ansimar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ansimar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ansimar suppliers with NDC on PharmaCompass.
Ansimar 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 Ansimar GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ansimar GMP manufacturer or Ansimar GMP API supplier for your needs.
A Ansimar CoA (Certificate of Analysis) is a formal document that attests to Ansimar's compliance with Ansimar specifications and serves as a tool for batch-level quality control.
Ansimar CoA mostly includes findings from lab analyses of a specific batch. For each Ansimar 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.
Ansimar may be tested according to a variety of international standards, such as European Pharmacopoeia (Ansimar EP), Ansimar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ansimar USP).
