API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
63
PharmaCompass offers a list of Alogliptin Benzoate 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 Alogliptin Benzoate manufacturer or Alogliptin Benzoate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alogliptin Benzoate manufacturer or Alogliptin Benzoate supplier.
PharmaCompass also assists you with knowing the Alogliptin Benzoate API Price utilized in the formulation of products. Alogliptin Benzoate API Price is not always fixed or binding as the Alogliptin Benzoate Price is obtained through a variety of data sources. The Alogliptin Benzoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A SCHEMBL476231 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SCHEMBL476231, including repackagers and relabelers. The FDA regulates SCHEMBL476231 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SCHEMBL476231 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 SCHEMBL476231 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SCHEMBL476231 supplier is an individual or a company that provides SCHEMBL476231 active pharmaceutical ingredient (API) or SCHEMBL476231 finished formulations upon request. The SCHEMBL476231 suppliers may include SCHEMBL476231 API manufacturers, exporters, distributors and traders.
click here to find a list of SCHEMBL476231 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SCHEMBL476231 DMF (Drug Master File) is a document detailing the whole manufacturing process of SCHEMBL476231 active pharmaceutical ingredient (API) in detail. Different forms of SCHEMBL476231 DMFs exist exist since differing nations have different regulations, such as SCHEMBL476231 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SCHEMBL476231 DMF submitted to regulatory agencies in the US is known as a USDMF. SCHEMBL476231 USDMF includes data on SCHEMBL476231's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SCHEMBL476231 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SCHEMBL476231 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 SCHEMBL476231 Drug Master File in Japan (SCHEMBL476231 JDMF) empowers SCHEMBL476231 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 SCHEMBL476231 JDMF during the approval evaluation for pharmaceutical products. At the time of SCHEMBL476231 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 SCHEMBL476231 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 SCHEMBL476231 Drug Master File in Korea (SCHEMBL476231 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SCHEMBL476231. The MFDS reviews the SCHEMBL476231 KDMF as part of the drug registration process and uses the information provided in the SCHEMBL476231 KDMF to evaluate the safety and efficacy of the drug.
After submitting a SCHEMBL476231 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 SCHEMBL476231 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SCHEMBL476231 suppliers with KDMF on PharmaCompass.
A SCHEMBL476231 written confirmation (SCHEMBL476231 WC) is an official document issued by a regulatory agency to a SCHEMBL476231 manufacturer, verifying that the manufacturing facility of a SCHEMBL476231 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SCHEMBL476231 APIs or SCHEMBL476231 finished pharmaceutical products to another nation, regulatory agencies frequently require a SCHEMBL476231 WC (written confirmation) as part of the regulatory process.
click here to find a list of SCHEMBL476231 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 SCHEMBL476231 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SCHEMBL476231 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 SCHEMBL476231 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 SCHEMBL476231 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SCHEMBL476231 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SCHEMBL476231 suppliers with NDC on PharmaCompass.
SCHEMBL476231 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 SCHEMBL476231 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 SCHEMBL476231 GMP manufacturer or SCHEMBL476231 GMP API supplier for your needs.
A SCHEMBL476231 CoA (Certificate of Analysis) is a formal document that attests to SCHEMBL476231's compliance with SCHEMBL476231 specifications and serves as a tool for batch-level quality control.
SCHEMBL476231 CoA mostly includes findings from lab analyses of a specific batch. For each SCHEMBL476231 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.
SCHEMBL476231 may be tested according to a variety of international standards, such as European Pharmacopoeia (SCHEMBL476231 EP), SCHEMBL476231 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SCHEMBL476231 USP).