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  • TABLET;ORAL - 12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CAPSULE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 100MG;25MG
  • TABLET;ORAL - 200MG;50MG
  • TABLET;ORAL - 100MG

Looking for 155213-67-5 / Ritonavir API manufacturers, exporters & distributors?

Ritonavir manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ritonavir

Synonyms

155213-67-5, Norvir, Abt-538, A-84538, Abbott 84538, Abbott-84538

Cas Number

155213-67-5

Unique Ingredient Identifier (UNII)

O3J8G9O825

About Ritonavir

An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV. It also inhibits CYTOCHROME P-450 CYP3A.

Ritonavir Manufacturers

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

Ritonavir Suppliers

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

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

Ritonavir USDMF

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

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

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

Ritonavir KDMF

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

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

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

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

Ritonavir CEP

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

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

Ritonavir WC

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

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

Ritonavir 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 Ritonavir as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ritonavir GMP

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

Ritonavir CoA

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

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

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