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List of Certificates of Suitability (CEPs) for Vitamin D3 Active Pharmaceutical Ingredient issued by the EDQM and listed on PharmaCompass.com

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API SUPPLIERS
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US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

JDMFs Filed

JDMFs Filed

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API REF. PRICE (USD / KG)
625
INTERMEDIATES

0

DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

Europe

Europe

Canada

Canada

Australia

Australia

0

South Africa

South Africa

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Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

0

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EXCIPIENTS
PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

0

USFDA Exclusivities

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JP

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R1-CEP 2005-098 - Rev 03
Withdrawn by Holder
Chemical and TSE
2012-02-07
2023-07-20
72
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R1-CEP 2007-347 - Rev 00
Valid
Chemical and TSE
2014-07-18
575
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Flag India
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R1-CEP 2007-292 - Rev 03
Valid
Chemical and TSE
2023-01-24
72
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R0-CEP 2021-089 - Rev 00
Valid
Chemical and TSE
2022-07-29
575
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R1-CEP 2016-266 - Rev 00
Valid
Chemical and TSE
2021-12-21
72
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R0-CEP 2013-282 - Rev 00
Withdrawn by Holder
Chemical and TSE
2015-09-10
2019-03-20
72
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R0-CEP 2021-055 - Rev 00
Valid
Chemical and TSE
2022-11-16
575
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R0-CEP 2019-003 - Rev 00
Valid
Chemical and TSE
2020-11-23
574
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R1-CEP 2015-199 - Rev 00
Valid
Chemical and TSE
2021-09-03
574
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R0-CEP 2019-351 - Rev 00
Valid
Chemical and TSE
2020-05-18
72
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R1-CEP 2009-050 - Rev 01
Valid
Chemical and TSE
2016-05-25
72
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R1-CEP 2003-036 - Rev 01
Valid
Chemical and TSE
2008-12-19
72
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Flag Belgium
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R0-CEP 2000-065 - Rev 02
Withdrawn by Holder
Chemical and TSE
2005-03-18
2006-08-01
72
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R0-CEP 2017-211 - Rev 03
Valid
Chemical and TSE
2022-05-12
72
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  • SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
  • SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
  • TABLET;ORAL - EQ 70MG BASE;2,800 IU
  • TABLET;ORAL - EQ 70MG BASE;5,600 IU

Looking for 67-97-0 / Vitamin D3 API manufacturers, exporters & distributors?

Vitamin D3 manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Vitamin D3 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 Vitamin D3 manufacturer or Vitamin D3 supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vitamin D3 manufacturer or Vitamin D3 supplier.

PharmaCompass also assists you with knowing the Vitamin D3 API Price utilized in the formulation of products. Vitamin D3 API Price is not always fixed or binding as the Vitamin D3 Price is obtained through a variety of data sources. The Vitamin D3 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Vitamin D3

Synonyms

67-97-0, Colecalciferol, Calciol, Oleovitamin d3, Ricketon, Arachitol

Cas Number

67-97-0

About Vitamin D3

Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24.

Vitamin D3 Manufacturers

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

Vitamin D3 Suppliers

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

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

Vitamin D3 CEP

A Vitamin D3 CEP of the European Pharmacopoeia monograph is often referred to as a Vitamin D3 Certificate of Suitability (COS). The purpose of a Vitamin D3 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vitamin D3 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vitamin D3 to their clients by showing that a Vitamin D3 CEP has been issued for it. The manufacturer submits a Vitamin D3 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vitamin D3 CEP holder for the record. Additionally, the data presented in the Vitamin D3 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vitamin D3 DMF.

A Vitamin D3 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vitamin D3 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Vitamin D3 suppliers with CEP (COS) on PharmaCompass.

Vitamin D3 Manufacturers | Traders | Suppliers

Vitamin D3 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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