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

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Valcyte
South Africa

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Valcyte

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 22 USDMF, 2 CEP/COS, 10 EU WC, 19 NDC API, 20 Listed Suppliers, $ API Reference Price

42 API Suppliers
22 USDMF
2 CEP/COS
10 EU WC
19 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

24 Drugs in Development

24 Drugs in Development

INTERMEDIATES

9 Intermediates Suppliers

9 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

91 FDF Dossiers, 18 FDA Orange Book, 45 Europe, 6 Canada, 9 Australia, 5 South Africa, 8 Listed Dossiers

91 FDF Dossiers
18 FDA Orange Book
45 Europe
6 Canada
9 Australia
5 South Africa
8 Listed Dossiers

RELATED EXCIPIENT COMPANIES

5 Rochem International Inc, 15 SPI Pharma, 2 Seqens, 4 DKSH, 1 Pharm-RX Chemical, 5 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Capital Farma, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 24 BASF, 1 Bioplus Life Sciences, 2 Clariant, 10 Corel Pharma Chem, 2 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 34 Solubilizers, 31 Controlled & Modified Release, 29 Direct Compression, 27 Thickeners and Stabilizers, 20 Parenteral, 20 Topical, 19 Taste Masking, 18 Lubricants & Glidants, 18 Granulation, 16 Film Formers & Plasticizers, 16 Co-Processed Excipients, 13 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 9 API Stability Enhancers, 8 Disintegrants & Superdisintegrants, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Rheology Modifiers

60 Fillers, Diluents & Binders
53 Coating Systems & Additives
34 Solubilizers
31 Controlled & Modified Release
29 Direct Compression
27 Thickeners and Stabilizers
20 Parenteral
20 Topical
19 Taste Masking
18 Lubricants & Glidants
18 Granulation
16 Film Formers & Plasticizers
16 Co-Processed Excipients
13 Chewable & Orodispersible Aids
11 Emulsifying Agents
9 API Stability Enhancers
8 Disintegrants & Superdisintegrants
6 Surfactant & Foaming Agents
5 Empty Capsules
4 Vegetarian Capsules
4 Coloring Agents
4 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 31 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
31 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 16 Finished Drug Prices, 1 Annual Reports

2 US Medicaid Prescriptions
16 Finished Drug Prices
1 Annual Reports

MARKET PLACE

8 APIs, 10 FDF Dossiers

8 APIs
10 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 2 Health Canada Patents

2 US Patents
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 2 Others

2 USP
2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,640 Xls

Filters

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5 All

01 1Pharmacare Limited, Woodmead

02 1Cipla Medpro (Pty) Ltd

03 1Hetero Drugs South Africa (Pty) Ltd

04 2Pharmaco Distribution (Pty) Ltd

filter Active Ingredients Reset all filters

5 All

01 4Valganciclovir

02 1Valganciclovir Hydrochloride

filter Dosage Form Reset all filters

5 All

01 3FCT

02 1POW

03 1TAB

filter Brand Name Reset all filters

5 All

01 1Cytameg

02 1Valcyte 450

03 1Valcyte 50mg/ml

04 1Valhet 450

05 1Valvir 450

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Valganciclovir

Brand Name : Cytameg

Dosage Form : FCT

Dosage Strength : 450mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Cipla Medpro (Pty) Ltd

Antibody Engineering

Not Confirmed

Cipla Medpro (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Valganciclovir

Brand Name : Valvir 450

Dosage Form : FCT

Dosage Strength : 450mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Hetero Drugs South Africa (Pty) Ltd

Antibody Engineering

Not Confirmed

Hetero Drugs South Africa (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Valganciclovir

Brand Name : Valhet 450

Dosage Form : FCT

Dosage Strength : 450mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Pharmaco Distribution (Pty) Ltd

Antibody Engineering

Not Confirmed

Pharmaco Distribution (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Valganciclovir

Brand Name : Valcyte 450

Dosage Form : TAB

Dosage Strength : 450mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Pharmaco Distribution (Pty) Ltd

Antibody Engineering

Not Confirmed

Pharmaco Distribution (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Valganciclovir Hydrochloride

Brand Name : Valcyte 50mg/ml

Dosage Form : POW

Dosage Strength : 50mg/ml

Packaging : 100X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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Digital Content

Corporate PDF

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