Cholecalciferol, meets USP testing specifications | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Cholecalciferol, Meets USP Testing Specifications
South Africa

Trusted Global CDMO Partner Delivering End-to-End Pharma Manufacturing & Development Solutions.

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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

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Topscience Biotech specializes in R&D, production, sales of Sodium Hyaluronate, focusing on Cosmetics, Medical, Pharmaceutical Grade HA

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Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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AMI Lifesciences is Driven by Chemistry. Powered by People.

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China

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Cholecalciferol, meets USP testing specifications

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

51 API Suppliers, 19 USDMF, 15 CEP/COS, 2 JDMF, 6 EU WC, 4 NDC API, 22 Listed Suppliers, $ API Reference Price

51 API Suppliers
19 USDMF
15 CEP/COS
2 JDMF
6 EU WC
4 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

8 Drugs in Development

8 Drugs in Development

FINISHED DOSAGE FORMULATIONS

743 FDF Dossiers, 6 FDA Orange Book, 397 Europe, 37 Canada, 6 South Africa, 297 Listed Dossiers

743 FDF Dossiers
6 FDA Orange Book
397 Europe
37 Canada
6 South Africa
297 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

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

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 12 Rochem International Inc, 19 SPI Pharma, 18 DKSH, 2 Pharm-RX Chemical, 10 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 32 BASF, 1 Bioplus Life Sciences, 1 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 33 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 12 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 35 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 Silverline Chemicals, 4 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

102 Fillers, Diluents & Binders, 57 Coating Systems & Additives, 49 Thickeners and Stabilizers, 40 Taste Masking, 37 Solubilizers, 34 Direct Compression, 32 Controlled & Modified Release, 29 Granulation, 27 Topical, 27 Parenteral, 25 Film Formers & Plasticizers, 23 Disintegrants & Superdisintegrants, 20 Chewable & Orodispersible Aids, 18 Co-Processed Excipients, 18 Lubricants & Glidants, 16 Rheology Modifiers, 12 Emulsifying Agents, 9 Empty Capsules, 8 API Stability Enhancers, 6 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Soft Gelatin

102 Fillers, Diluents & Binders
57 Coating Systems & Additives
49 Thickeners and Stabilizers
40 Taste Masking
37 Solubilizers
34 Direct Compression
32 Controlled & Modified Release
29 Granulation
27 Topical
27 Parenteral
25 Film Formers & Plasticizers
23 Disintegrants & Superdisintegrants
20 Chewable & Orodispersible Aids
18 Co-Processed Excipients
18 Lubricants & Glidants
16 Rheology Modifiers
12 Emulsifying Agents
9 Empty Capsules
8 API Stability Enhancers
6 Surfactant & Foaming Agents
4 Vegetarian Capsules
4 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 25 News #PharmaBuzz

2 Data Compilation #PharmaFlow
25 News #PharmaBuzz

GLOBAL SALES INFORMATION

361 Regulatory FDF Prices, 5 Annual Reports

361 Regulatory FDF Prices
5 Annual Reports

MARKET PLACE

85 APIs, 23 FDF Dossiers

85 APIs
23 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 1 JP, 3 Others

3 EDQM
3 USP
1 JP
3 Others

ANALYTICAL

3 Analytical Methods

3 Analytical Methods

$ API Ref.Price (USD/KG) : 611 Xls

Filters

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Filters

FILTER :

filter Applicant Reset all filters

6 All

01 2Adcock Ingram Critical Care (Pty) Ltd

02 1Austell Pharmaceuticals (Pty) Ltd

03 1MSD (Pty) Ltd

04 1Organon

05 1Pharma Dynamics (Pty) Ltd

filter Active Ingredients Reset all filters

6 All

01 1CHOLECALCIFEROL

02 3Cholecalciferol

03 1Colecalciferol

04 1Colechalciferol

filter Dosage Form Reset all filters

6 All

01 1CAP

02 2INJ

03 3TAB

filter Brand Name Reset all filters

6 All

01 2Cernevit

02 1Fosavance

03 1Fosavance 5 600

04 1Osteonate Plus 5600 once a week

05 1Soskain

List of Suppliers

Product Main Page

01

Adcock Ingram Critical Care (Pty) Ltd

IMCAS Asia

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

IMCAS Asia

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Cholecalciferol

Brand Name : Cernevit

Dosage Form : INJ

Dosage Strength : 220iu/Vial

Packaging : 5X10iu/Vial

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Adcock Ingram Critical Care (Pty) Ltd

IMCAS Asia

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

IMCAS Asia

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Cholecalciferol

Brand Name : Cernevit

Dosage Form : INJ

Dosage Strength : 220iu/Vial

Packaging : 5X1iu/Vial

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Austell Pharmaceuticals (Pty) Ltd

IMCAS Asia

Not Confirmed

Austell Pharmaceuticals (Pty) Ltd

IMCAS Asia

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

CHOLECALCIFEROL

Brand Name : Soskain

Dosage Form : CAP

Dosage Strength : 50000IU

Packaging : 96X1IU

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Corporate PDF

04

MSD (Pty) Ltd

IMCAS Asia

Not Confirmed

MSD (Pty) Ltd

IMCAS Asia

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Colecalciferol

Brand Name : Fosavance

Dosage Form : TAB

Dosage Strength : 2800mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Organon

IMCAS Asia

Not Confirmed

Organon

IMCAS Asia

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Colechalciferol

Brand Name : Fosavance 5 600

Dosage Form : TAB

Dosage Strength : 5600I.U.

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Pharma Dynamics (Pty) Ltd

IMCAS Asia

Not Confirmed

Pharma Dynamics (Pty) Ltd

IMCAS Asia

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Cholecalciferol

Brand Name : Osteonate Plus 5600 once a week

Dosage Form : TAB

Dosage Strength : 5600IU

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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