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List of Drug Master Files (KDMF) for Cinacalcet Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Dongbang FTL Co., Ltd. (1)

02 Guobang Pharmaceutical Co., Ltd.@[Act 2] Zhejiang Guobang Pharmaceutical Co., Ltd (1)

03 Hetero Drugs Limited (Unit-IX) (2)

04 Ind Swift Laboratories Limited (1)

05 Jeil Pharmaceutical Co., Ltd. (1)

06 Kyungbo Pharmaceutical Co., Ltd. (1)

07 Okayama Plant, Oita Works, Sumitomo Chemical Company, Limited (1)

08 Solara Active Pharma Sciences Limited (3)

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01 Dongbang FTL Co., Ltd. (1)

02 Hwail Pharmaceutical Co., Ltd. (1)

03 Jeil Pharmaceutical Co., Ltd. (1)

04 Kookjeon Pharmaceutical Co., Ltd. (2)

05 Kyowa Kirin Korea Co., Ltd. (1)

06 Kyungbo Pharmaceutical Co., Ltd. (1)

07 Pharmapia Co., Ltd. (2)

08 Sungwoo Chemical Co., Ltd. (1)

09 VOnBio Co., Ltd. (1)

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01 Cinacalcet hydrochloride (11)

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01 India (6)

02 Japan (1)

03 South Korea (4)

URL Supplier Web Content
Dongbang FTL Co., Ltd.
2016-02-24
1731-15-ND
Dongbang FTL Co., Ltd.
South Korea
78, Jaekongdan 4-gil, Hya...
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Pharmapia Co., Ltd.
2018-04-20
Number 331-4-ND(1)
Hetero Drugs Limited (Uni...
India
Unit-IX, Plot No.1, Heter...
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Hwail Pharmaceutical Co., Ltd.
2016-11-18
Number 331-4-ND
Hetero Drugs Limited (Uni...
India
Unit-IX, Plot No.1, Heter...
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Kookjeon Pharmaceutical Co., Ltd.
2016-08-10
Number 4749-18-ND
Ind Swift Laboratories Li...
India
Village Bhagwanpur, Barwa...
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Jeil Pharmaceutical Co., Ltd.
2015-08-31
1668-16-ND
Jeil Pharmaceutical Co., ...
South Korea
7 Cheonggangachang-ro, Ba...
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Kookjeon Pharmaceutical Co., Ltd.
2017-04-07
2520-21-ND
Guobang Pharmaceutical Co...
South Korea
8@No.6 , Balangongdan-ro,...
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Kyungbo Pharmaceutical Co., Ltd.
2016-04-07
1673-18-ND
Kyungbo Pharmaceutical Co...
South Korea
174 Silok-ro, Asan-si, Ch...
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Sungwoo Chemical Co., Ltd.
2015-10-15
Number 4579-5-ND
Solara Active Pharma Scie...
India
RS No.33 & 34 Mather Road...
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VOnBio Co., Ltd.
2020-06-05
Number 4579-5-ND(2)
Solara Active Pharma Scie...
India
RS No.33 & 34 Mather Road...
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Pharmapia Co., Ltd.
2016-09-21
Number 4579-5-ND(1)
Solara Active Pharma Scie...
India
RS No.33 & 34 Mather Road...
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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 Manufacturers

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

Cinacalcet Suppliers

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

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

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

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

CLICK HERE to find a list of Cinacalcet suppliers with KDMF on PharmaCompass.

Cinacalcet Manufacturers | Traders | Suppliers

Cinacalcet Manufacturers, Traders, Suppliers 1
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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