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Levocetirizine

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ACTIVE PHARMA INGREDIENTS

54 API Suppliers, 14 USDMF, 3 CEP/COS, 4 JDMF, 16 EU WC, 24 KDMF, 17 NDC API, 42 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

11 Intermediate Suppliers

11 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

234 FDF Dossiers, 29 FDA Orange Book, 60 Europe, 42 South Africa, 103 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 2.5MG/5ML, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 3 Rochem International Inc, 1 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 5 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 10 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 35 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 25 Thickeners and Stabilizers, 23 Controlled & Modified Release, 16 Direct Compression, 15 Solubilizers, 14 Film Formers & Plasticizers, 14 Disintegrants & Superdisintegrants, 14 Granulation, 13 Taste Masking, 13 Topical, 11 Parenteral, 10 Lubricants & Glidants, 9 Co-Processed Excipients, 7 Emulsifying Agents, 7 Rheology Modifiers, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Chewable & Orodispersible Aids, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

24 News #PharmaBuzz

24 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 59 Regulatory FDF Prices, 7 Annual Reports

MARKET PLACE

44 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents

1 US Patents

REF. STANDARDS & IMPURITIES

2 USP, 9 Others

ANALYTICAL

4 BioAnalytical Methods

4 BioAnalytical Methods

$ Xls download

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	Granules India Limited	India	GRANULES INDIA LTD	22898	LEVOCETIRIZINE DIHYDROCHLORIDE USP	2009-05-22	Active	II	Complete	2022-03-09	2022-02-08
28/03/2025	Metrochem API Private Limited	India	METROCHEM API PRIVATE LTD	34731	LEVOCETIRIZINE DIHYDROCHLORIDE USP	2020-05-12	Active	II	N/A

Levocetirizine

Levocetirizine

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

54 API Suppliers

14 USDMF

3 CEP/COS

4 JDMF

16 EU WC

24 KDMF

17 NDC API

42 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

11 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

234 FDF Dossiers

29 FDA Orange Book

60 Europe

42 South Africa

103 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 2.5MG/5ML

TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

3 Rochem International Inc

1 SPI Pharma

7 DKSH

1 Pharm-RX Chemical

4 Faran Shimi Pharmaceutical

5 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 ACG Worldwide

10 Actylis

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

10 BASF

1 Bioplus Life Sciences

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

1 Finar

9 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

35 Kerry

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

1 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

17 Roquette

12 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

2 The Dow Chemical Company

3 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders

47 Coating Systems & Additives

25 Thickeners and Stabilizers

23 Controlled & Modified Release

16 Direct Compression

15 Solubilizers

14 Film Formers & Plasticizers

14 Disintegrants & Superdisintegrants

14 Granulation

TABLET;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;ORAL - 2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons