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