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Looking for 59467-70-8 / Midazolam API manufacturers, exporters & distributors?

Midazolam manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Midazolam 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 Midazolam manufacturer or Midazolam supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Midazolam manufacturer or Midazolam supplier.

PharmaCompass also assists you with knowing the Midazolam API Price utilized in the formulation of products. Midazolam API Price is not always fixed or binding as the Midazolam Price is obtained through a variety of data sources. The Midazolam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Midazolam

Synonyms

Dormicum, 59467-70-8, Versed, 8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo[1,5-a][1,4]benzodiazepine, Midazolamum, Buccolam

Cas Number

59467-70-8

Unique Ingredient Identifier (UNII)

R60L0SM5BC

About Midazolam

A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.

08J Manufacturers

A 08J manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 08J, including repackagers and relabelers. The FDA regulates 08J manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 08J 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 08J manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

08J Suppliers

A 08J supplier is an individual or a company that provides 08J active pharmaceutical ingredient (API) or 08J finished formulations upon request. The 08J suppliers may include 08J API manufacturers, exporters, distributors and traders.

click here to find a list of 08J suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

08J USDMF

A 08J DMF (Drug Master File) is a document detailing the whole manufacturing process of 08J active pharmaceutical ingredient (API) in detail. Different forms of 08J DMFs exist exist since differing nations have different regulations, such as 08J USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 08J DMF submitted to regulatory agencies in the US is known as a USDMF. 08J USDMF includes data on 08J's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 08J USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 08J suppliers with USDMF on PharmaCompass.

08J JDMF

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 08J Drug Master File in Japan (08J JDMF) empowers 08J 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 08J JDMF during the approval evaluation for pharmaceutical products. At the time of 08J 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 08J suppliers with JDMF on PharmaCompass.

08J KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a 08J Drug Master File in Korea (08J KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 08J. The MFDS reviews the 08J KDMF as part of the drug registration process and uses the information provided in the 08J KDMF to evaluate the safety and efficacy of the drug.

After submitting a 08J 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 08J API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 08J suppliers with KDMF on PharmaCompass.

08J CEP

A 08J CEP of the European Pharmacopoeia monograph is often referred to as a 08J Certificate of Suitability (COS). The purpose of a 08J CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 08J EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 08J to their clients by showing that a 08J CEP has been issued for it. The manufacturer submits a 08J CEP (COS) as part of the market authorization procedure, and it takes on the role of a 08J CEP holder for the record. Additionally, the data presented in the 08J CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 08J DMF.

A 08J CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 08J 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 08J suppliers with CEP (COS) on PharmaCompass.

08J WC

A 08J written confirmation (08J WC) is an official document issued by a regulatory agency to a 08J manufacturer, verifying that the manufacturing facility of a 08J active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 08J APIs or 08J finished pharmaceutical products to another nation, regulatory agencies frequently require a 08J WC (written confirmation) as part of the regulatory process.

click here to find a list of 08J suppliers with Written Confirmation (WC) on PharmaCompass.

08J NDC

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 08J as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 08J API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 08J 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain 08J and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 08J NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 08J suppliers with NDC on PharmaCompass.

08J GMP

08J 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 08J 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 08J GMP manufacturer or 08J GMP API supplier for your needs.

08J CoA

A 08J CoA (Certificate of Analysis) is a formal document that attests to 08J's compliance with 08J specifications and serves as a tool for batch-level quality control.

08J CoA mostly includes findings from lab analyses of a specific batch. For each 08J 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.

08J may be tested according to a variety of international standards, such as European Pharmacopoeia (08J EP), 08J JP (Japanese Pharmacopeia) and the US Pharmacopoeia (08J USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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