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Find Cinacalcet Hydrochloride manufacturers, exporters & distributors on PharmaCompass

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Looking for 364782-34-3 / Cinacalcet API manufacturers, exporters & distributors?

Cinacalcet manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Cinacalcet

Synonyms

364782-34-3, Cinacalcet hcl, Sensipar, Mimpara, Amg073 hcl, Regpara

Cas Number

364782-34-3

Unique Ingredient Identifier (UNII)

1K860WSG25

About Cinacalcet

Cinacalcet Hydrochloride is the orally bioavailable hydrochloride salt of the calcimimetic cinacalcet. Cinacalcet increases the sensitivity of calcium-sensing receptors on chief cells in the parathyroid gland to extracellular calcium, thereby reducing parathyroid hormone (PTH) secretion. A reduction in PTH levels inhibits osteoclast activity, which may result in a decrease in cortical bone turnover and bone fibrosis, and normalization of serum calcium and phosphorus levels. In addition, by reducing PTH levels, cinacalcet may reduce PSA levels; PTH appears to raise PSA levels and may increase prostate cancer cell growth.

Cinacalcet Hydrochloride Manufacturers

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

Cinacalcet Hydrochloride Suppliers

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

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

Cinacalcet Hydrochloride USDMF

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

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

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

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

Cinacalcet Hydrochloride KDMF

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

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

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

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

Cinacalcet Hydrochloride WC

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

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

Cinacalcet 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 Cinacalcet Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Cinacalcet Hydrochloride GMP

Cinacalcet 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 Cinacalcet 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 Cinacalcet Hydrochloride GMP manufacturer or Cinacalcet Hydrochloride GMP API supplier for your needs.

Cinacalcet Hydrochloride CoA

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

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

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