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Klacid XL

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ACTIVE PHARMA INGREDIENTS

117 API Suppliers, 23 USDMF, 21 CEP/COS, 16 JDMF, 6 EU WC, 59 KDMF, 12 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

509 FDF Dossiers, 50 FDA Orange Book, 229 Europe, 24 Canada, 8 Australia, 39 South Africa, 159 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML, FOR SUSPENSION;ORAL - 250MG/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 3 Rochem International Inc, 9 SPI Pharma, 15 DKSH, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 6 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 28 BASF, 2 Clariant, 14 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 12 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 34 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 15 Microlex e.U, 3 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 4 Silverline Chemical, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 76 Coating Systems & Additives, 40 Controlled & Modified Release, 37 Thickeners and Stabilizers, 37 Solubilizers, 30 Disintegrants & Superdisintegrants, 27 Topical, 25 Granulation, 24 Lubricants & Glidants, 24 Direct Compression, 22 Film Formers & Plasticizers, 20 Parenteral, 15 Taste Masking, 14 Co-Processed Excipients, 14 Emulsifying Agents, 10 Chewable & Orodispersible Aids, 9 Rheology Modifiers, 8 API Stability Enhancers, 7 Surfactant & Foaming Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

27 News #PharmaBuzz

27 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 206 Regulatory FDF Prices

MARKET PLACE

42 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

57 Health Canada Patents

57 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 8 USP, 10 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Century Pharmaceuticals	India	CENTURY PHARMACEUTICALS LTD	34800	CLARITHROMYCIN USP	2020-07-22	Active	II	N/A
28/03/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	15276	CLARITHROMYCIN USP	2001-02-06	Active	II	Complete	2012-11-30	2012-11-13

Klacid XL

Klacid XL

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

117 API Suppliers

23 USDMF

21 CEP/COS

16 JDMF

6 EU WC

59 KDMF

12 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

21 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

509 FDF Dossiers

50 FDA Orange Book

229 Europe

24 Canada

8 Australia

39 South Africa

159 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 125MG/5ML

FOR SUSPENSION;ORAL - 250MG/5ML

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **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**

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

2 Evonik

3 Rochem International Inc

9 SPI Pharma

15 DKSH

1 Pharm-RX Chemical

6 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

6 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Pramukh Pharmachem

1 Zeal MediPharma

1 ACG Worldwide

9 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

28 BASF

2 Clariant

14 Corel Pharma Chem

6 DFE Pharma

2 Finar

13 Gangwal Chemicals

12 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

34 Kerry

3 Kima Chemical

6 Lonza Capsugel

1 Lubrizol Life Science Health

15 Microlex e.U

3 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

6 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

25 Roquette

TABLET;ORAL - 250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG 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

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons