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Looking for 104376-79-6 / Ceftriaxone API manufacturers, exporters & distributors?

Ceftriaxone manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ceftriaxone

Synonyms

Ceftriaxone sodium, 74578-69-1, 104376-79-6, Ro-139904, Ceftriaxone sodium salt, Octx

Cas Number

104376-79-6

About Ceftriaxone

A broad-spectrum cephalosporin antibiotic and cefotaxime derivative with a very long half-life and high penetrability to meninges, eyes and inner ears.

Ceftriaxone Disodium Salt Hemiheptahydrate Manufacturers

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

Ceftriaxone Disodium Salt Hemiheptahydrate Suppliers

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

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

Ceftriaxone Disodium Salt Hemiheptahydrate USDMF

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

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

click here to find a list of Ceftriaxone Disodium Salt Hemiheptahydrate suppliers with USDMF on PharmaCompass.

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

Ceftriaxone Disodium Salt Hemiheptahydrate KDMF

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

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

After submitting a Ceftriaxone Disodium Salt Hemiheptahydrate 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 Ceftriaxone Disodium Salt Hemiheptahydrate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Ceftriaxone Disodium Salt Hemiheptahydrate suppliers with KDMF on PharmaCompass.

Ceftriaxone Disodium Salt Hemiheptahydrate CEP

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

A Ceftriaxone Disodium Salt Hemiheptahydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ceftriaxone Disodium Salt Hemiheptahydrate 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 Ceftriaxone Disodium Salt Hemiheptahydrate suppliers with CEP (COS) on PharmaCompass.

Ceftriaxone Disodium Salt Hemiheptahydrate WC

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

click here to find a list of Ceftriaxone Disodium Salt Hemiheptahydrate suppliers with Written Confirmation (WC) on PharmaCompass.

Ceftriaxone Disodium Salt Hemiheptahydrate 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 Ceftriaxone Disodium Salt Hemiheptahydrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ceftriaxone Disodium Salt Hemiheptahydrate 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 Ceftriaxone Disodium Salt Hemiheptahydrate 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 Ceftriaxone Disodium Salt Hemiheptahydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ceftriaxone Disodium Salt Hemiheptahydrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Ceftriaxone Disodium Salt Hemiheptahydrate suppliers with NDC on PharmaCompass.

Ceftriaxone Disodium Salt Hemiheptahydrate GMP

Ceftriaxone Disodium Salt Hemiheptahydrate 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 Ceftriaxone Disodium Salt Hemiheptahydrate 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 Ceftriaxone Disodium Salt Hemiheptahydrate GMP manufacturer or Ceftriaxone Disodium Salt Hemiheptahydrate GMP API supplier for your needs.

Ceftriaxone Disodium Salt Hemiheptahydrate CoA

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

Ceftriaxone Disodium Salt Hemiheptahydrate CoA mostly includes findings from lab analyses of a specific batch. For each Ceftriaxone Disodium Salt Hemiheptahydrate 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.

Ceftriaxone Disodium Salt Hemiheptahydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ceftriaxone Disodium Salt Hemiheptahydrate EP), Ceftriaxone Disodium Salt Hemiheptahydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ceftriaxone Disodium Salt Hemiheptahydrate 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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