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Looking for 914462-92-3 / Rolapitant HCl API manufacturers, exporters & distributors?

Rolapitant HCl manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Rolapitant HCl

Synonyms

Rolapitant hydrochloride hydrate, 914462-92-3, Varubi, Sch619734, Rolapitant hcl h20, Rolapitant hydrochloride [usan]

Cas Number

914462-92-3

Unique Ingredient Identifier (UNII)

57O5S1QSAQ

About Rolapitant HCl

Rolapitant Hydrochloride is the hydrochloride salt form of rolapitant, an orally bioavailable, centrally-acting, selective, neurokinin 1 receptor (NK1-receptor) antagonist with potential antiemetic activity. Upon oral administration, rolapitant competitively binds to and blocks the activity of the NK1-receptor in the central nervous system, thereby inhibiting the binding of the endogenous ligand, substance P (SP). This may prevent both SP-induced emesis and chemotherapy-induced nausea and vomiting (CINV). The interaction of SP with the NK1-receptor plays a key role in the induction of nausea and vomiting caused by emetogenic cancer chemotherapy. Compared to other NK1-receptor antagonists, rolapitant has both a more rapid onset of action and a much longer half-life.

Rolapitant hydrochloride Manufacturers

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

Rolapitant hydrochloride Suppliers

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

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

Rolapitant hydrochloride USDMF

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

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

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

Rolapitant hydrochloride 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 Rolapitant hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Rolapitant hydrochloride GMP

Rolapitant hydrochloride 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 Rolapitant hydrochloride 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 Rolapitant hydrochloride GMP manufacturer or Rolapitant hydrochloride GMP API supplier for your needs.

Rolapitant hydrochloride CoA

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

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

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