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Looking for 171099-57-3 / Oritavancin API manufacturers, exporters & distributors?

Oritavancin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Oritavancin

Synonyms

171099-57-3, Ly333328, Oritavancin [inn], Ly-333328, Chlorobiphenyl-chloroeremomycin, Pug62frz2e

Cas Number

171099-57-3

Unique Ingredient Identifier (UNII)

PUG62FRZ2E

About Oritavancin

Oritavancin is a glycopeptide antibiotic used for the treatment of skin infections. It was developed by The Medicines Company (acquired by Novartis). Oritavancin was initially approved by the FDA in 2014 and formulated to combat susceptible gram-positive bacteria that cause skin and skin structure infections. It boasts the option of single-dose administration and has been proven as non-inferior to a full course of [vancomycin] therapy. On March 12, 2021 the FDA approved Kimyrsa, a complete course of therapy in a single, 1 hour 1200 mg infusion. Orbactiv, the other FDA approved oritavancin product, is administered over a 3 hour infusion and contains a lower dose of 400 mg. Marketed by Melinta Therapeutics, Kimyrsa offers effective and time-efficient treatment for skin and skin structure infections.

Oritavancin Manufacturers

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

Oritavancin Suppliers

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

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

Oritavancin 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 Oritavancin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Oritavancin GMP

Oritavancin 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 Oritavancin 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 Oritavancin GMP manufacturer or Oritavancin GMP API supplier for your needs.

Oritavancin CoA

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

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

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