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Looking for 856867-55-5 / Tedizolid API manufacturers, exporters & distributors?

Tedizolid manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Tedizolid

Synonyms

856867-55-5, Torezolid phosphate, Tr-701fa, Tr-701 fa, Tedizolid (phosphate), Tedizolid phosphate [usan]

Cas Number

856867-55-5

Unique Ingredient Identifier (UNII)

O7DRJ6R4DW

About Tedizolid

Drug-resistant bacteria, such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, and penicillin-resistant Streptococcus penumoniae, represent a massive public health threat. Tedizolid is a member of the oxazolidinone class of antibiotics, which includes the previously approved [linezolid] and is generally effective against multidrug-resistant Gram-positive bacteria. Tedizolid is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is generally more effective and more tolerable than [linezolid]. Tedizolid was approved by the FDA on June 20, 2014, for sale by Cubist Pharmaceuticals as tedizolid phosphate (SIVEXTRO). This product is currently available as both an oral tablet and as a powder for intravenous injection.

Torezolid Phosphate Manufacturers

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

Torezolid Phosphate Suppliers

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

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

Torezolid Phosphate USDMF

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

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

click here to find a list of Torezolid Phosphate suppliers with USDMF on PharmaCompass.

Torezolid Phosphate KDMF

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

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

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

click here to find a list of Torezolid Phosphate suppliers with KDMF on PharmaCompass.

Torezolid Phosphate 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 Torezolid Phosphate as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Torezolid Phosphate suppliers with NDC on PharmaCompass.

Torezolid Phosphate GMP

Torezolid Phosphate 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 Torezolid Phosphate 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 Torezolid Phosphate GMP manufacturer or Torezolid Phosphate GMP API supplier for your needs.

Torezolid Phosphate CoA

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

Torezolid Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Torezolid Phosphate 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.

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