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  • SOLUTION;INJECTION - 100MG/10ML (10MG/ML)
  • SOLUTION;INJECTION - 100MG/20ML (5MG/ML)
  • SOLUTION;INJECTION - 150MG/30ML (5MG/ML)
  • SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML)
  • SOLUTION;INJECTION - 1GM/200ML (5MG/ML)
  • SOLUTION;INJECTION - 200MG/20ML (10MG/ML)
  • SOLUTION;INJECTION - 200MG/100ML (2MG/ML)
  • SOLUTION;INJECTION - 20MG/10ML (2MG/ML)
  • SOLUTION;INJECTION - 400MG/200ML (2MG/ML)
  • SOLUTION;INJECTION - 40MG/20ML (2MG/ML)
  • SOLUTION;INJECTION - 500MG/100ML (5MG/ML)
  • SOLUTION;INJECTION - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INJECTION - 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 84057-95-4 / Ropivacaine Hydrochloride API manufacturers, exporters & distributors?

Ropivacaine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ropivacaine Hydrochloride

Synonyms

84057-95-4, (s)-ropivacaine, Naropin, Ropivacaine [inn], Ropivacaina, Ropivacainum

Cas Number

84057-95-4

Unique Ingredient Identifier (UNII)

7IO5LYA57N

About Ropivacaine Hydrochloride

An anilide used as a long-acting local anesthetic. It has a differential blocking effect on sensory and motor neurons.

Ropivacaine Manufacturers

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

Ropivacaine Suppliers

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

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

Ropivacaine USDMF

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

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

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

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

Ropivacaine KDMF

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

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

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

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

Ropivacaine CEP

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

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

Ropivacaine WC

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

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

Ropivacaine 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 Ropivacaine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ropivacaine GMP

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

Ropivacaine CoA

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

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

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