Diltiazem Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Diltiazem Hydrochloride
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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Diltiazem Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 20 USDMF, 8 CEP/COS, 5 JDMF, 5 EU WC, 6 KDMF, 17 NDC API, 22 Listed Suppliers, $ API Reference Price

42 API Suppliers
20 USDMF
8 CEP/COS
5 JDMF
5 EU WC
6 KDMF
17 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

346 FDF Dossiers, 222 FDA Orange Book, 18 Europe, 78 Canada, 7 South Africa, 21 Listed Dossiers

346 FDF Dossiers
222 FDA Orange Book
18 Europe
78 Canada
7 South Africa
21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 120MG, TABLET;ORAL - 30MG, TABLET;ORAL - 60MG, TABLET;ORAL - 90MG, CAPSULE, EXTENDED RELEASE;ORAL - 120MG, CAPSULE, EXTENDED RELEASE;ORAL - 180MG, CAPSULE, EXTENDED RELEASE;ORAL - 240MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG, CAPSULE, EXTENDED RELEASE;ORAL - 360MG, CAPSULE, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 120MG, CAPSULE, EXTENDED RELEASE;ORAL - 180MG, CAPSULE, EXTENDED RELEASE;ORAL - 240MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG, CAPSULE, EXTENDED RELEASE;ORAL - 360MG, CAPSULE, EXTENDED RELEASE;ORAL - 420MG, TABLET, EXTENDED RELEASE;ORAL - 120MG, TABLET, EXTENDED RELEASE;ORAL - 180MG, TABLET, EXTENDED RELEASE;ORAL - 240MG, TABLET, EXTENDED RELEASE;ORAL - 300MG, TABLET, EXTENDED RELEASE;ORAL - 360MG, TABLET, EXTENDED RELEASE;ORAL - 420MG

TABLET;ORAL - 120MG
TABLET;ORAL - 30MG
TABLET;ORAL - 60MG
TABLET;ORAL - 90MG
CAPSULE, EXTENDED RELEASE;ORAL - 120MG
CAPSULE, EXTENDED RELEASE;ORAL - 180MG
CAPSULE, EXTENDED RELEASE;ORAL - 240MG
CAPSULE, EXTENDED RELEASE;ORAL - 300MG
CAPSULE, EXTENDED RELEASE;ORAL - 360MG
CAPSULE, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 120MG
CAPSULE, EXTENDED RELEASE;ORAL - 180MG
CAPSULE, EXTENDED RELEASE;ORAL - 240MG
CAPSULE, EXTENDED RELEASE;ORAL - 300MG
CAPSULE, EXTENDED RELEASE;ORAL - 360MG
CAPSULE, EXTENDED RELEASE;ORAL - 420MG
TABLET, EXTENDED RELEASE;ORAL - 120MG
TABLET, EXTENDED RELEASE;ORAL - 180MG
TABLET, EXTENDED RELEASE;ORAL - 240MG
TABLET, EXTENDED RELEASE;ORAL - 300MG
TABLET, EXTENDED RELEASE;ORAL - 360MG
TABLET, EXTENDED RELEASE;ORAL - 420MG

RELATED EXCIPIENT COMPANIES

5 Evonik, 4 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 9 DKSH, 8 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 32 BASF, 22 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 31 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 9 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 33 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 3 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

102 Fillers, Diluents & Binders, 73 Coating Systems & Additives, 58 Controlled & Modified Release, 43 Direct Compression, 38 Thickeners and Stabilizers, 36 Solubilizers, 30 Granulation, 30 Taste Masking, 28 Film Formers & Plasticizers, 22 Parenteral, 22 Lubricants & Glidants, 22 Co-Processed Excipients, 21 Disintegrants & Superdisintegrants, 17 Chewable & Orodispersible Aids, 16 Topical, 11 Emulsifying Agents, 9 Empty Capsules, 7 API Stability Enhancers, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

102 Fillers, Diluents & Binders
73 Coating Systems & Additives
58 Controlled & Modified Release
43 Direct Compression
38 Thickeners and Stabilizers
36 Solubilizers
30 Granulation
30 Taste Masking
28 Film Formers & Plasticizers
22 Parenteral
22 Lubricants & Glidants
22 Co-Processed Excipients
21 Disintegrants & Superdisintegrants
17 Chewable & Orodispersible Aids
16 Topical
11 Emulsifying Agents
9 Empty Capsules
7 API Stability Enhancers
7 Rheology Modifiers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

33 NEWS #PharmaBuzz

33 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 63 Finished Drug Prices, 1 Annual Reports

7 US Medicaid Prescriptions
63 Finished Drug Prices
1 Annual Reports

MARKET PLACE

13 APIs, 1 FDF Dossiers

13 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

25 Health Canada Patents

25 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 2 Others

3 EDQM
3 USP
2 Others

ANALYTICAL

2 Analytical Methods

2 Analytical Methods

$ API Ref.Price (USD/KG) : 94 Xls

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01 5Adcock Ingram Limited

02 2Pfizer Laboratories (Pty) Ltd

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01 7Diltiazem Hydrochloride

filter Dosage Form Reset all filters

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01 4SRC

02 3TAB

filter Brand Name Reset all filters

7 All

01 1Adco-Zildem 180 mg SR

02 1Adco-Zildem 240 SR

03 2Adco-Zildem 60

04 1Adco-Zildem 90

05 1Tilazem 180 Cr

06 1Tilazem 240 Cr

List of Suppliers

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01

Adcock Ingram Limited

Antibody Engineering

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Adcock Ingram Limited

Antibody Engineering

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Regulatory Info : Generic

Registration Country : South Africa

Diltiazem Hydrochloride

Brand Name : Adco-Zildem 60

Dosage Form : TAB

Dosage Strength : 60mg

Packaging : 50X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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02

Adcock Ingram Limited

Antibody Engineering

Not Confirmed

Adcock Ingram Limited

Antibody Engineering

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Regulatory Info : Generic

Registration Country : South Africa

Diltiazem Hydrochloride

Brand Name : Adco-Zildem 60

Dosage Form : TAB

Dosage Strength : 60mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Corporate PDF

03

Adcock Ingram Limited

Antibody Engineering

Not Confirmed

Adcock Ingram Limited

Antibody Engineering

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Regulatory Info : Generic

Registration Country : South Africa

Diltiazem Hydrochloride

Brand Name : Adco-Zildem 90

Dosage Form : TAB

Dosage Strength : 90mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Adcock Ingram Limited

Antibody Engineering

Not Confirmed

Adcock Ingram Limited

Antibody Engineering

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Regulatory Info : Generic

Registration Country : South Africa

Diltiazem Hydrochloride

Brand Name : Adco-Zildem 180 mg SR

Dosage Form : SRC

Dosage Strength : 180mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

Adcock Ingram Limited

Antibody Engineering

Not Confirmed

Adcock Ingram Limited

Antibody Engineering

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Diltiazem Hydrochloride

Brand Name : Adco-Zildem 240 SR

Dosage Form : SRC

Dosage Strength : 240mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Pfizer Laboratories (Pty) Ltd

Antibody Engineering

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Pfizer Laboratories (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Diltiazem Hydrochloride

Brand Name : Tilazem 180 Cr

Dosage Form : SRC

Dosage Strength : 180mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Pfizer Laboratories (Pty) Ltd

Antibody Engineering

Not Confirmed

Pfizer Laboratories (Pty) Ltd

Antibody Engineering

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Diltiazem Hydrochloride

Brand Name : Tilazem 240 Cr

Dosage Form : SRC

Dosage Strength : 240mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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