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List of Drug Master Files (KDMF) for 1,25-dihydroxy vitamin D3 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Cerbios-Pharma (1)

02 CARBOGEN AMCIS B.V. (1)

03 Corden Pharma Colorado, Inc. (1)

04 Formosa Laboratories, Inc. (2)

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01 Farmirae Co., Ltd. (1)

02 GP Therapeutics Korea Co., Ltd. (1)

03 Hanmi Pharmaceutical Co., Ltd. (1)

04 Pharmaline Co., Ltd. (1)

05 Sungjin Exim Co., Ltd. (1)

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01 Calcitriol (5)

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01 Germany (1)

02 Switzerland (2)

03 Taiwan (2)

URL Supplier Web Content
Pharmaline Co., Ltd.
2021-03-18
20210318-209-J-696
Cerbios-Pharma
Switzerland
6900 Via Figino 6, CH-691...
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Sungjin Exim Co., Ltd.
2021-07-05
20210705-209-J-512
CARBOGEN AMCIS B.V.
Netherlands
Nieuweweg 2a, 3901 BE Vee...
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GP Therapeutics Korea Co., Ltd.
2021-04-29
20210429-209-J-962
Corden Pharma Colorado, I...
U.S.A
2075 55th Street, Boulder...
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Farmirae Co., Ltd.
2021-04-12
20210412-209-J-577
Formosa Laboratories, Inc...
Taiwan
36 Hoping Street, Louchu,...
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Hanmi Pharmaceutical Co., Ltd.
2022-01-12
20210412-209-J-577(1)
Formosa Laboratories, Inc...
Taiwan
No. 36 & 36-1 Hoping Stre...
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Looking for 32222-06-3 / Calcitriol API manufacturers, exporters & distributors?

Calcitriol manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Calcitriol

Synonyms

32222-06-3, Rocaltrol, Calcijex, Topitriol, 1alpha,25-dihydroxyvitamin d3, Silkis

Cas Number

32222-06-3

Unique Ingredient Identifier (UNII)

FXC9231JVH

About Calcitriol

The physiologically active form of vitamin D. It is formed primarily in the kidney by enzymatic hydroxylation of 25-hydroxycholecalciferol (CALCIFEDIOL). Its production is stimulated by low blood calcium levels and parathyroid hormone. Calcitriol increases intestinal absorption of calcium and phosphorus, and in concert with parathyroid hormone increases bone resorption.

1,25-dihydroxy vitamin D3 Manufacturers

A 1,25-dihydroxy vitamin D3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,25-dihydroxy vitamin D3, including repackagers and relabelers. The FDA regulates 1,25-dihydroxy vitamin D3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,25-dihydroxy vitamin D3 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 1,25-dihydroxy vitamin D3 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

1,25-dihydroxy vitamin D3 Suppliers

A 1,25-dihydroxy vitamin D3 supplier is an individual or a company that provides 1,25-dihydroxy vitamin D3 active pharmaceutical ingredient (API) or 1,25-dihydroxy vitamin D3 finished formulations upon request. The 1,25-dihydroxy vitamin D3 suppliers may include 1,25-dihydroxy vitamin D3 API manufacturers, exporters, distributors and traders.

click here to find a list of 1,25-dihydroxy vitamin D3 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

1,25-dihydroxy vitamin D3 KDMF

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

Pharmaceutical companies submit a 1,25-dihydroxy vitamin D3 Drug Master File in Korea (1,25-dihydroxy vitamin D3 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,25-dihydroxy vitamin D3. The MFDS reviews the 1,25-dihydroxy vitamin D3 KDMF as part of the drug registration process and uses the information provided in the 1,25-dihydroxy vitamin D3 KDMF to evaluate the safety and efficacy of the drug.

After submitting a 1,25-dihydroxy vitamin D3 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 1,25-dihydroxy vitamin D3 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 1,25-dihydroxy vitamin D3 suppliers with KDMF on PharmaCompass.

1,25-dihydroxy vitamin D3 Manufacturers | Traders | Suppliers

1,25-dihydroxy vitamin D3 Manufacturers, Traders, Suppliers 1
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We have 4 companies offering 1,25-dihydroxy vitamin D3

Get in contact with the supplier of your choice:

  1. Cerbios-Pharma SA
  2. CARBOGEN AMCIS AG
  3. CordenPharma
  4. Formosa Laboratories
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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