Synopsis
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CEP/COS
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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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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27585
Submission : 2013-11-27
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-14
Pay. Date : 2013-03-20
DMF Number : 26978
Submission : 2013-06-21
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22770
Submission : 2009-05-12
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Registration Number : 305MF10081
Registrant's Address : Plot No. 2G, 2H, 2I, Udyog Vihar, Greater Noida-201 308 (U.P.) India
Initial Date of Registration : 2023-07-12
Latest Date of Registration : 2023-07-12
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
Date of Issue : 2023-09-29
Valid Till : 2026-09-28
Written Confirmation Number : WC-0570
Address of the Firm : Plot No. 112, 113, 114, GIDC Estate Gozariya, Mehsana-382825, Gujarat, India
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Date of Issue : 2025-04-24
Valid Till : 2028-05-25
Written Confirmation Number : WC-0002
Address of the Firm : Plot No. A-2, A-2/1, A-/2, UPSIDC Industrial Area, Bijnor Road, Gajraula -244235...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Registrant Name : Korea Pharma Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-210-J-324
Manufacturer Name : Chunghwa Chemical Synthesis ...
Manufacturer Address : 1, Tung-Hsing St., Shu-Lin, New Taipei City 23850, Taiwan
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-03-17
Registration Number : 20210317-210-J-758
Manufacturer Name : Teva API India Private Limit...
Manufacturer Address : Plot No.: A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula-244 235, D...
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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...
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, ...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
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...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.
About the Company : Fishfa Biogenics, a division of Fishfa Rubbers Ltd., is a leading manufacturer and supplier of high-quality biological APIs. With GLP labs and WHO-GMP-certified facilities, Fishfa ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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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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DOSAGE - POWDER;INTRAVENOUS - 50MG/VIAL
USFDA APPLICATION NUMBER - 21227
DOSAGE - POWDER;INTRAVENOUS - 70MG/VIAL
USFDA APPLICATION NUMBER - 21227
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Chewable & Orodispersible Aids
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ABOUT THIS PAGE
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PharmaCompass offers a list of Caspofungin 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 Caspofungin manufacturer or Caspofungin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Caspofungin manufacturer or Caspofungin supplier.
PharmaCompass also assists you with knowing the Caspofungin API Price utilized in the formulation of products. Caspofungin API Price is not always fixed or binding as the Caspofungin Price is obtained through a variety of data sources. The Caspofungin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CASPO manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CASPO, including repackagers and relabelers. The FDA regulates CASPO manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CASPO 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 CASPO manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CASPO supplier is an individual or a company that provides CASPO active pharmaceutical ingredient (API) or CASPO finished formulations upon request. The CASPO suppliers may include CASPO API manufacturers, exporters, distributors and traders.
click here to find a list of CASPO suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CASPO DMF (Drug Master File) is a document detailing the whole manufacturing process of CASPO active pharmaceutical ingredient (API) in detail. Different forms of CASPO DMFs exist exist since differing nations have different regulations, such as CASPO USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CASPO DMF submitted to regulatory agencies in the US is known as a USDMF. CASPO USDMF includes data on CASPO's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CASPO USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CASPO 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 CASPO Drug Master File in Japan (CASPO JDMF) empowers CASPO 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 CASPO JDMF during the approval evaluation for pharmaceutical products. At the time of CASPO 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 CASPO 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 CASPO Drug Master File in Korea (CASPO KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CASPO. The MFDS reviews the CASPO KDMF as part of the drug registration process and uses the information provided in the CASPO KDMF to evaluate the safety and efficacy of the drug.
After submitting a CASPO 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 CASPO API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CASPO suppliers with KDMF on PharmaCompass.
A CASPO written confirmation (CASPO WC) is an official document issued by a regulatory agency to a CASPO manufacturer, verifying that the manufacturing facility of a CASPO active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CASPO APIs or CASPO finished pharmaceutical products to another nation, regulatory agencies frequently require a CASPO WC (written confirmation) as part of the regulatory process.
click here to find a list of CASPO 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 CASPO as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CASPO 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 CASPO 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 CASPO and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CASPO NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CASPO suppliers with NDC on PharmaCompass.
CASPO 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 CASPO 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 CASPO GMP manufacturer or CASPO GMP API supplier for your needs.
A CASPO CoA (Certificate of Analysis) is a formal document that attests to CASPO's compliance with CASPO specifications and serves as a tool for batch-level quality control.
CASPO CoA mostly includes findings from lab analyses of a specific batch. For each CASPO 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.
CASPO may be tested according to a variety of international standards, such as European Pharmacopoeia (CASPO EP), CASPO JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CASPO USP).
