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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited is a globally recognized, technology-driven manufacturer of APIs , CDMO & formulations, established in 1987. Headquartered in Mumbai, India, we operate ...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
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...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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Pfanstiehl
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral
Excipient Details : Tris (hydroxymethyl) aminomethane is used in electrophoresis, protein purification, enzyme assay, and as a buffering agent in biologics production.
Pharmacopoeia Ref : USP, EP, BP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Tris Base
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Tris (hydroxymethyl) aminomethane is a buffering agent used in cell culture, downstream and biological formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Tris Base
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PharmaCompass offers a list of Iohexol 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 Iohexol manufacturer or Iohexol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Iohexol manufacturer or Iohexol supplier.
PharmaCompass also assists you with knowing the Iohexol API Price utilized in the formulation of products. Iohexol API Price is not always fixed or binding as the Iohexol Price is obtained through a variety of data sources. The Iohexol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DSSTox_CID_3157 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSSTox_CID_3157, including repackagers and relabelers. The FDA regulates DSSTox_CID_3157 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSSTox_CID_3157 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 DSSTox_CID_3157 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DSSTox_CID_3157 supplier is an individual or a company that provides DSSTox_CID_3157 active pharmaceutical ingredient (API) or DSSTox_CID_3157 finished formulations upon request. The DSSTox_CID_3157 suppliers may include DSSTox_CID_3157 API manufacturers, exporters, distributors and traders.
click here to find a list of DSSTox_CID_3157 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DSSTox_CID_3157 DMF (Drug Master File) is a document detailing the whole manufacturing process of DSSTox_CID_3157 active pharmaceutical ingredient (API) in detail. Different forms of DSSTox_CID_3157 DMFs exist exist since differing nations have different regulations, such as DSSTox_CID_3157 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DSSTox_CID_3157 DMF submitted to regulatory agencies in the US is known as a USDMF. DSSTox_CID_3157 USDMF includes data on DSSTox_CID_3157's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSSTox_CID_3157 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DSSTox_CID_3157 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 DSSTox_CID_3157 Drug Master File in Japan (DSSTox_CID_3157 JDMF) empowers DSSTox_CID_3157 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 DSSTox_CID_3157 JDMF during the approval evaluation for pharmaceutical products. At the time of DSSTox_CID_3157 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 DSSTox_CID_3157 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 DSSTox_CID_3157 Drug Master File in Korea (DSSTox_CID_3157 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DSSTox_CID_3157. The MFDS reviews the DSSTox_CID_3157 KDMF as part of the drug registration process and uses the information provided in the DSSTox_CID_3157 KDMF to evaluate the safety and efficacy of the drug.
After submitting a DSSTox_CID_3157 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 DSSTox_CID_3157 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of DSSTox_CID_3157 suppliers with KDMF on PharmaCompass.
A DSSTox_CID_3157 CEP of the European Pharmacopoeia monograph is often referred to as a DSSTox_CID_3157 Certificate of Suitability (COS). The purpose of a DSSTox_CID_3157 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DSSTox_CID_3157 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DSSTox_CID_3157 to their clients by showing that a DSSTox_CID_3157 CEP has been issued for it. The manufacturer submits a DSSTox_CID_3157 CEP (COS) as part of the market authorization procedure, and it takes on the role of a DSSTox_CID_3157 CEP holder for the record. Additionally, the data presented in the DSSTox_CID_3157 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DSSTox_CID_3157 DMF.
A DSSTox_CID_3157 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DSSTox_CID_3157 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of DSSTox_CID_3157 suppliers with CEP (COS) 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 DSSTox_CID_3157 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DSSTox_CID_3157 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 DSSTox_CID_3157 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 DSSTox_CID_3157 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DSSTox_CID_3157 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DSSTox_CID_3157 suppliers with NDC on PharmaCompass.
DSSTox_CID_3157 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 DSSTox_CID_3157 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 DSSTox_CID_3157 GMP manufacturer or DSSTox_CID_3157 GMP API supplier for your needs.
A DSSTox_CID_3157 CoA (Certificate of Analysis) is a formal document that attests to DSSTox_CID_3157's compliance with DSSTox_CID_3157 specifications and serves as a tool for batch-level quality control.
DSSTox_CID_3157 CoA mostly includes findings from lab analyses of a specific batch. For each DSSTox_CID_3157 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.
DSSTox_CID_3157 may be tested according to a variety of international standards, such as European Pharmacopoeia (DSSTox_CID_3157 EP), DSSTox_CID_3157 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DSSTox_CID_3157 USP).
