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Pseudoephedrine Hydrochloride

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ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 25 USDMF, 10 CEP/COS, 1 JDMF, 3 EU WC, 6 KDMF, 12 NDC API, 13 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

313 FDF Dossiers, 112 FDA Orange Book, 3 Europe, 114 Canada, 50 South Africa, 34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;30MG, CAPSULE;ORAL - 8MG;60MG, TABLET, EXTENDED RELEASE;ORAL - 240MG, TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG, CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG, TABLET;ORAL - 2MG;200MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG, TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG, TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG, SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML, SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 9 Rochem International Inc, 22 SPI Pharma, 15 DKSH, 2 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 12 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 9 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 4 ACG Worldwide, 15 Actylis, 4 Aeon Procare, 3 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 38 BASF, 1 Bioplus Life Sciences, 2 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 14 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 18 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 10 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 37 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

121 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 48 Direct Compression, 47 Disintegrants & Superdisintegrants, 46 Thickeners and Stabilizers, 41 Controlled & Modified Release, 37 Granulation, 37 Taste Masking, 36 Solubilizers, 34 Film Formers & Plasticizers, 32 Topical, 29 Lubricants & Glidants, 28 Parenteral, 25 Chewable & Orodispersible Aids, 19 Co-Processed Excipients, 11 Rheology Modifiers, 10 Emulsifying Agents, 10 API Stability Enhancers, 9 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 31 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 Regulatory FDF Prices

1 Regulatory FDF Prices

MARKET PLACE

25 APIs

25 APIs

PATENTS & EXCLUSIVITIES

1 US Patents

1 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 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	Malladi Drugs & Pharmaceuticals Limited	India	NOVUS FINE CHEMICALS LLC	2516	PSEUDOEPHEDRINE HCL, SULFATE, AND BASE BULK POWDER	1975-08-28	Active	II	N/A
28/03/2025	Malladi Drugs & Pharmaceuticals Limited	India	MALLADI DRUGS AND PHARMACEUTICALS LTD	10320	D-PSEUDOEPHEDRINE HYDROCHLORIDE	1993-06-24	Active	II	Complete	2014-03-25	2014-03-14

Pseudoephedrine Hydrochloride

Pseudoephedrine Hydrochloride

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

39 API Suppliers

25 USDMF

10 CEP/COS

1 JDMF

3 EU WC

6 KDMF

12 NDC API

13 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

313 FDF Dossiers

112 FDA Orange Book

3 Europe

114 Canada

50 South Africa

34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;30MG

CAPSULE;ORAL - 8MG;60MG

TABLET, EXTENDED RELEASE;ORAL - 240MG

TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG

CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

TABLET;ORAL - 2MG;200MG;30MG

TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG

TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG

TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG

SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML

SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Minakem

9 Rochem International Inc

22 SPI Pharma

15 DKSH

2 Pharm-RX Chemical

9 Faran Shimi Pharmaceutical

12 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

9 Gangwal Healthcare

12 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 Pramukh Pharmachem

1 Zeal MediPharma

4 ACG Worldwide

15 Actylis

4 Aeon Procare

3 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

38 BASF

1 Bioplus Life Sciences

2 Clariant

12 Corel Pharma Chem

7 DFE Pharma

2 Finar

14 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

4 Kima Chemical

6 Lonza Capsugel

2 Lubrizol Life Science Health

18 Microlex e.U

2 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

5 Novo Excipients

5 Pharmatrans-Sanaq

10 Pluviaendo

SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;ORAL - 5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons