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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 240MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 300MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 350MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Liquid Injection
Dosage Strength : 755MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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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 OMNIPAQUE 350 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of OMNIPAQUE 350, including repackagers and relabelers. The FDA regulates OMNIPAQUE 350 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. OMNIPAQUE 350 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 OMNIPAQUE 350 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A OMNIPAQUE 350 supplier is an individual or a company that provides OMNIPAQUE 350 active pharmaceutical ingredient (API) or OMNIPAQUE 350 finished formulations upon request. The OMNIPAQUE 350 suppliers may include OMNIPAQUE 350 API manufacturers, exporters, distributors and traders.
click here to find a list of OMNIPAQUE 350 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A OMNIPAQUE 350 DMF (Drug Master File) is a document detailing the whole manufacturing process of OMNIPAQUE 350 active pharmaceutical ingredient (API) in detail. Different forms of OMNIPAQUE 350 DMFs exist exist since differing nations have different regulations, such as OMNIPAQUE 350 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A OMNIPAQUE 350 DMF submitted to regulatory agencies in the US is known as a USDMF. OMNIPAQUE 350 USDMF includes data on OMNIPAQUE 350's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The OMNIPAQUE 350 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of OMNIPAQUE 350 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 OMNIPAQUE 350 Drug Master File in Japan (OMNIPAQUE 350 JDMF) empowers OMNIPAQUE 350 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 OMNIPAQUE 350 JDMF during the approval evaluation for pharmaceutical products. At the time of OMNIPAQUE 350 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 OMNIPAQUE 350 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 OMNIPAQUE 350 Drug Master File in Korea (OMNIPAQUE 350 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of OMNIPAQUE 350. The MFDS reviews the OMNIPAQUE 350 KDMF as part of the drug registration process and uses the information provided in the OMNIPAQUE 350 KDMF to evaluate the safety and efficacy of the drug.
After submitting a OMNIPAQUE 350 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 OMNIPAQUE 350 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of OMNIPAQUE 350 suppliers with KDMF on PharmaCompass.
A OMNIPAQUE 350 CEP of the European Pharmacopoeia monograph is often referred to as a OMNIPAQUE 350 Certificate of Suitability (COS). The purpose of a OMNIPAQUE 350 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of OMNIPAQUE 350 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of OMNIPAQUE 350 to their clients by showing that a OMNIPAQUE 350 CEP has been issued for it. The manufacturer submits a OMNIPAQUE 350 CEP (COS) as part of the market authorization procedure, and it takes on the role of a OMNIPAQUE 350 CEP holder for the record. Additionally, the data presented in the OMNIPAQUE 350 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the OMNIPAQUE 350 DMF.
A OMNIPAQUE 350 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. OMNIPAQUE 350 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 OMNIPAQUE 350 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 OMNIPAQUE 350 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for OMNIPAQUE 350 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 OMNIPAQUE 350 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 OMNIPAQUE 350 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a OMNIPAQUE 350 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of OMNIPAQUE 350 suppliers with NDC on PharmaCompass.
OMNIPAQUE 350 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 OMNIPAQUE 350 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 OMNIPAQUE 350 GMP manufacturer or OMNIPAQUE 350 GMP API supplier for your needs.
A OMNIPAQUE 350 CoA (Certificate of Analysis) is a formal document that attests to OMNIPAQUE 350's compliance with OMNIPAQUE 350 specifications and serves as a tool for batch-level quality control.
OMNIPAQUE 350 CoA mostly includes findings from lab analyses of a specific batch. For each OMNIPAQUE 350 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.
OMNIPAQUE 350 may be tested according to a variety of international standards, such as European Pharmacopoeia (OMNIPAQUE 350 EP), OMNIPAQUE 350 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (OMNIPAQUE 350 USP).
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