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List of Drug Master Files (JDMF) for Cinacalcet Hydrochloride Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 HETERO DRUGS LIMITED. (1)

02 JEIL PHARMACEUTICAL CO. , LTD. (1)

03 KUKJEON PHARMACEUTICAL Co. , Ltd. (1)

04 Sanyo Chemical Research Institute Co., Ltd. (1)

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01 Cinacalcet Hydrochloride (3)

02 Cinacalcet hydrochloride (1)

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01 Gabon (1)

02 India (1)

03 South Korea (2)

URL Supplier Web Content
230MF10003
7-2-A2, Hetero Corporate, Industria...
2018-01-10
2018-01-10
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301MF10033
343, Sapyeong-daero, Seocho-gu, Seo...
2019-07-19
2019-07-19
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URL Supplier Web Content
230MF10125
#1516, Geumgang Penterium IT Tower,...
2020-03-02
2018-09-03
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Sanyo Chemical Research Institute C...

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Virtual Booth Virtual Booth
Digital Content Digital Content
URL Supplier Web Content
301MF10098
148-1 Tajii, Mihara Ward, Sakai Cit...
2019-11-27
2019-11-27
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Looking for 364782-34-3 / Cinacalcet API manufacturers, exporters & distributors?

Cinacalcet manufacturers, exporters & distributors 1

96

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 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 Manufacturers | Traders | Suppliers

Cinacalcet Hydrochloride Manufacturers, Traders, Suppliers 1
86

We have 3 companies offering Cinacalcet Hydrochloride

Get in contact with the supplier of your choice:

  1. Hetero Drugs
  2. Jeil Pharmaceutical Co., Ltd
  3. Kukjeon Pharmaceutical
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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