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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
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Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
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, ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
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...
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 ...
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PharmaCompass offers a list of Anidulafungin 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 Anidulafungin manufacturer or Anidulafungin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Anidulafungin manufacturer or Anidulafungin supplier.
PharmaCompass also assists you with knowing the Anidulafungin API Price utilized in the formulation of products. Anidulafungin API Price is not always fixed or binding as the Anidulafungin Price is obtained through a variety of data sources. The Anidulafungin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Anidulafungin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anidulafungin, including repackagers and relabelers. The FDA regulates Anidulafungin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anidulafungin 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 Anidulafungin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Anidulafungin supplier is an individual or a company that provides Anidulafungin active pharmaceutical ingredient (API) or Anidulafungin finished formulations upon request. The Anidulafungin suppliers may include Anidulafungin API manufacturers, exporters, distributors and traders.
click here to find a list of Anidulafungin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Anidulafungin DMF (Drug Master File) is a document detailing the whole manufacturing process of Anidulafungin active pharmaceutical ingredient (API) in detail. Different forms of Anidulafungin DMFs exist exist since differing nations have different regulations, such as Anidulafungin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Anidulafungin DMF submitted to regulatory agencies in the US is known as a USDMF. Anidulafungin USDMF includes data on Anidulafungin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Anidulafungin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Anidulafungin 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 Anidulafungin Drug Master File in Korea (Anidulafungin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Anidulafungin. The MFDS reviews the Anidulafungin KDMF as part of the drug registration process and uses the information provided in the Anidulafungin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Anidulafungin 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 Anidulafungin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Anidulafungin suppliers with KDMF on PharmaCompass.
A Anidulafungin written confirmation (Anidulafungin WC) is an official document issued by a regulatory agency to a Anidulafungin manufacturer, verifying that the manufacturing facility of a Anidulafungin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Anidulafungin APIs or Anidulafungin finished pharmaceutical products to another nation, regulatory agencies frequently require a Anidulafungin WC (written confirmation) as part of the regulatory process.
click here to find a list of Anidulafungin 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 Anidulafungin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Anidulafungin 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 Anidulafungin 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 Anidulafungin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Anidulafungin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Anidulafungin suppliers with NDC on PharmaCompass.
Anidulafungin 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 Anidulafungin 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 Anidulafungin GMP manufacturer or Anidulafungin GMP API supplier for your needs.
A Anidulafungin CoA (Certificate of Analysis) is a formal document that attests to Anidulafungin's compliance with Anidulafungin specifications and serves as a tool for batch-level quality control.
Anidulafungin CoA mostly includes findings from lab analyses of a specific batch. For each Anidulafungin 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.
Anidulafungin may be tested according to a variety of international standards, such as European Pharmacopoeia (Anidulafungin EP), Anidulafungin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Anidulafungin USP).
