Niacin | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Niacin
South Africa

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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FAMAR CDMO- From early development to commercial manufacturing.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Niacin

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 9 USDMF, 3 CEP/COS, 5 EU WC, 4 NDC API, 12 Listed Suppliers, $ API Reference Price

22 API Suppliers
9 USDMF
3 CEP/COS
5 EU WC
4 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

82 FDF Dossiers, 54 FDA Orange Book, 4 Europe, 1 Canada, 2 South Africa, 21 Listed Dossiers

82 FDF Dossiers
54 FDA Orange Book
4 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TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 14 Rochem International Inc, 23 SPI Pharma, 2 Seqens, 18 DKSH, 2 Pharm-RX Chemical, 10 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 8 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Pramukh Pharmachem, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 3 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 36 BASF, 1 Bioplus Life Sciences, 2 Clariant, 15 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 34 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 12 Pluviaendo, 4 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, 11 Sigachi Industries, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

107 Fillers, Diluents & Binders, 77 Coating Systems & Additives, 50 Thickeners and Stabilizers, 44 Controlled & Modified Release, 41 Solubilizers, 40 Taste Masking, 37 Direct Compression, 31 Topical, 31 Parenteral, 30 Film Formers & Plasticizers, 30 Granulation, 28 Lubricants & Glidants, 27 Disintegrants & Superdisintegrants, 24 Chewable & Orodispersible Aids, 19 Co-Processed Excipients, 14 Emulsifying Agents, 13 Rheology Modifiers, 10 API Stability Enhancers, 9 Empty Capsules, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

107 Fillers, Diluents & Binders
77 Coating Systems & Additives
50 Thickeners and Stabilizers
44 Controlled & Modified Release
41 Solubilizers
40 Taste Masking
37 Direct Compression
31 Topical
31 Parenteral
30 Film Formers & Plasticizers
30 Granulation
28 Lubricants & Glidants
27 Disintegrants & Superdisintegrants
24 Chewable & Orodispersible Aids
19 Co-Processed Excipients
14 Emulsifying Agents
13 Rheology Modifiers
10 API Stability Enhancers
9 Empty Capsules
7 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

14 NEWS #PharmaBuzz

14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 11 Finished Drug Prices

3 US Medicaid Prescriptions
11 Finished Drug Prices

MARKET PLACE

18 APIs, 1 Intermediates

18 APIs
1 Intermediates

PATENTS & EXCLUSIVITIES

12 Health Canada Patents

12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 2 JP, 4 Others

2 EDQM
4 USP
2 JP
4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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

Filters

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FILTER :

filter Applicant Reset all filters

2 All

01 1Pharmacare Limited, Woodmead

02 1MSD (Pty) Ltd

filter Active Ingredients Reset all filters

2 All

01 1Niacin

02 1Nicotinic acid

filter Dosage Form Reset all filters

2 All

01 1CAP

02 1TAB

filter Brand Name Reset all filters

2 All

01 1Filibon

02 1Tredaptive

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

The Generic Rx Session

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Nicotinic acid

Brand Name : Filibon

Dosage Form : CAP

Dosage Strength : 10u

Packaging : 30X1u

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

MSD (Pty) Ltd

The Generic Rx Session

Not Confirmed

MSD (Pty) Ltd

The Generic Rx Session

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Tredaptive

Dosage Form : TAB

Dosage Strength : 1000mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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