Niacin | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Niacin
Europe

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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HealthTech BioActives, leading globally in Flavonoids and Vitamin B12 Derivatives.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Aspen API. More than just an API™

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FAMAR CDMO- From early development to commercial manufacturing.

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Niacin

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 9 USDMF, 3 CEP/COS, 3 EU WC, 2 KDMF, 4 NDC API, 12 Listed Suppliers, $ API Reference Price

21 API Suppliers
9 USDMF
3 CEP/COS
3 EU WC
2 KDMF
4 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

28 Drugs in Development

28 Drugs in Development

FINISHED DOSAGE FORMULATIONS

99 FDF Dossiers, 60 FDA Orange Book, 15 Europe, 1 Canada, 2 South Africa, 21 Listed Dossiers

99 FDF Dossiers
60 FDA Orange Book
15 Europe
1 Canada
2 South Africa
21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 3 Evonik, 13 Rochem International Inc, 23 SPI Pharma, 21 DKSH, 2 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 20 Kirsch Pharma, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 36 BASF, 1 Bioplus Life Sciences, 4 CD Formulation, 2 Clariant, 15 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 9 Ideal Cures, 4 Ingredion Pharma Solutions, 22 Kerry, 3 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 11 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 35 Roquette, 17 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

97 Fillers, Diluents & Binders, 71 Coating Systems & Additives, 58 Thickeners and Stabilizers, 46 Parenteral, 42 Solubilizers, 40 Controlled & Modified Release, 40 Taste Masking, 38 Direct Compression, 33 Topical, 33 Granulation, 29 Film Formers & Plasticizers, 27 Lubricants & Glidants, 25 Disintegrants & Superdisintegrants, 24 Chewable & Orodispersible Aids, 17 Rheology Modifiers, 16 Co-Processed Excipients, 14 Emulsifying Agents, 10 API Stability Enhancers, 9 Empty Capsules, 9 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

97 Fillers, Diluents & Binders
71 Coating Systems & Additives
58 Thickeners and Stabilizers
46 Parenteral
42 Solubilizers
40 Controlled & Modified Release
40 Taste Masking
38 Direct Compression
33 Topical
33 Granulation
29 Film Formers & Plasticizers
27 Lubricants & Glidants
25 Disintegrants & Superdisintegrants
24 Chewable & Orodispersible Aids
17 Rheology Modifiers
16 Co-Processed Excipients
14 Emulsifying Agents
10 API Stability Enhancers
9 Empty Capsules
9 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

16 News #PharmaBuzz

16 News #PharmaBuzz

GLOBAL SALES INFORMATION

10 US Medicaid Prescriptions, 11 Regulatory FDF Prices

10 US Medicaid Prescriptions
11 Regulatory FDF Prices

MARKET PLACE

18 APIs, 1 Intermediates

18 APIs
1 Intermediates

PATENTS & EXCLUSIVITIES

24 Health Canada Patents

24 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 JP, 5 Others

2 EDQM
1 USP
2 JP
5 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 6 Xls

Filters

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Filters

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15 All

01 4Abbott Scandinavia Ab

02 1Astrazeneca Ab

03 1Bayer Hispania Sl

04 3Laboratórios Basi

05 3Merck Sharp & Dohme Limited

06 1Nevada Pharma Ab

07 1Pannon

08 1Vefa Ilac

filter Active Ingredients Reset all filters

15 All

01 1Iron; Thiamine; Riboflavin; Niacin; Pyridoxine; Vitamin B 12; Folic Acid

02 3Laropiprant; Nicotinic Acid (Niacin)

03 1Niacin

04 1Nicotinic Acid; Salicylic Acid; Trometamol (Tris)

05 5Nikotinsyra

06 1Thiamine; Riboflavin; Niacin; Pantothenic Acid; Pyridoxine; Vitamin B 12; Biotin; Folic Acid

07 1Vitamin A; Ascorbic Acid; Ergocalciferol; Vitamin E; Thiamine; Riboflavin; Niacin; Pyridoxine; Vitamin B 12; Folic Acid

08 1Vitamin A; Thiamine; Riboflavin; Pyridoxine; Vitamin B 12; Ascorbic Acid; Vitamin E; Vitamin D3; Folic Acid; Niacin; Calcium D-pantothenate; Calcium; Copper; Iodine; Iron; Manganese Sulfate; Zinc; Magnesium

09 1Zinc Oxide; Folic Acid; Niacin; Calcium Carbonate; Iron Fumarate; Vitamin E; Vitamin B6; Vitamin D3; Vitamin B12; Vitamin B1; Vitamin B2; Vitamin C; Vitamin A

filter Dosage Form Reset all filters

15 All

01 1CAPSULE

02 1Capsule

03 1Effervescent Tablet

04 3Liquid Solution

05 3Modified Release Tablet

06 1Salve

07 5Tablet

filter Country Reset all filters

15 All

01 1Hungary

02 3Portugal

03 1Spain

04 9Sweden

05 1Turkey

filter Brand Name Reset all filters

15 All

01 1Acidium Nicotinicum Vasc

02 1Lunafem Soft Capsules

03 4Niaspan

04 1Nicangin

05 1Parvulex

06 1Pelzont

07 1Theranyl

08 1Three-Dimensional

09 1Trevaclyn

10 3Blank

List of Suppliers

Product Main Page

01

Abbott Scandinavia Ab

Organic Process R&D

Not Confirmed

Abbott Scandinavia Ab

Organic Process R&D

Not Confirmed

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Regulatory Info : Deregistered

Registration Country : Sweden

Nikotinsyra

Brand Name : Niaspan

Dosage Form : Tablet

Dosage Strength : 1000mg

Packaging :

Approval Date : 03/09/2004

Application Number : 20040607004142

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Laboratórios Basi

OPRD

Not Confirmed

Laboratórios Basi

OPRD

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Regulatory Info :

Registration Country : Portugal

Thiamine; Riboflavin; Niacin; Pantothenic Acid; Pyridoxine; Vitamin B 12; Biotin; Folic Acid

Brand Name :

Dosage Form : Liquid Solution

Dosage Strength :

Packaging : 1 Bottle- 100 ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Portugal

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Laboratórios Basi

OPRD

Not Confirmed

Laboratórios Basi

OPRD

Not Confirmed

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Regulatory Info :

Registration Country : Portugal

Iron; Thiamine; Riboflavin; Niacin; Pyridoxine; Vitamin B 12; Folic Acid

Brand Name :

Dosage Form : Liquid Solution

Dosage Strength :

Packaging : 1 Bottle- 200 ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Portugal

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04

Laboratórios Basi

OPRD

Not Confirmed

Laboratórios Basi

OPRD

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Regulatory Info :

Registration Country : Portugal

Vitamin A; Ascorbic Acid; Ergocalciferol; Vitamin E; Thiamine; Riboflavin; Niacin; Pyridoxine; Vitamin B 12; Folic Acid

Brand Name :

Dosage Form : Liquid Solution

Dosage Strength :

Packaging : 1 Bottle- 100 ML, 250 ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Portugal

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Merck Sharp & Dohme Limited

OPRD

Not Confirmed

Merck Sharp & Dohme Limited

OPRD

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Laropiprant; Nicotinic Acid (Niacin)

Brand Name : Pelzont

Dosage Form : Modified Release Tablet

Dosage Strength : 1000mg;20mg

Packaging :

Approval Date : 03/07/2008

Application Number : 20070914000032

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Merck Sharp & Dohme Limited

OPRD

Not Confirmed

Merck Sharp & Dohme Limited

OPRD

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Laropiprant; Nicotinic Acid (Niacin)

Brand Name : Three-Dimensional

Dosage Form : Modified Release Tablet

Dosage Strength : 1000mg;20mg

Packaging :

Approval Date : 03/07/2008

Application Number : 20070813000027

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Merck Sharp & Dohme Limited

OPRD

Not Confirmed

Merck Sharp & Dohme Limited

OPRD

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Laropiprant; Nicotinic Acid (Niacin)

Brand Name : Trevaclyn

Dosage Form : Modified Release Tablet

Dosage Strength : 1000mg;20mg

Packaging :

Approval Date : 03/07/2008

Application Number : 20070831000016

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Pannon

OPRD

Not Confirmed

Pannon

OPRD

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Hungary

Brand Name : Acidium Nicotinicum Vasc

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

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Corporate PDF

09

Vefa Ilac

OPRD

Not Confirmed

Vefa Ilac

OPRD

Not Confirmed

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Regulatory Info : Generic

Registration Country : Turkey

Vitamin A; Thiamine; Riboflavin; Pyridoxine; Vitamin B 12; Ascorbic Acid; Vitamin E; Vitamin D3; Folic Acid; Niacin; Calcium D-pantothenate; Calcium; Copper; Iodine; Iron; Manganese Sulfate; Zinc; Magnesium

Brand Name : Parvulex

Dosage Form : CAPSULE

Dosage Strength :

Packaging : 60 Softgel Capsules

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Nevada Pharma Ab

Country

OPRD

Not Confirmed

Nevada Pharma Ab

Country

OPRD

Not Confirmed

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Country

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Regulatory Info : Deregistered

Registration Country : Sweden

Nicotinic Acid; Salicylic Acid; Trometamol (Tris)

Brand Name : Theranyl

Dosage Form : Salve

Dosage Strength :

Packaging :

Approval Date : 16/05/1966

Application Number : 19660516000031

Regulatory Info : Deregistered

Registration Country : Sweden

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Website

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