Excipient Market Overview: Clariant sets up its first PEG excipients facility in US; India harmonizes 22 excipient monographs

DATA COMPILATION
#PharmaFlow

Pipeline Prospector March 2026 highlights: Lilly to acquire Centessa for US$ 7.8 bn; Merck buys Terns Pharma for US$ 6.7 bn

Stock Recap
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Oralet

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 13 USDMF, 11 CEP/COS, 4 JDMF, 2 EU WC, 4 KDMF, 14 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

552 FDF Dossiers, 77 FDA Orange Book, 431 Europe, 13 Canada, 3 South Africa, 28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE, TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 18 SPI Pharma, 2 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 5 Kirsch Pharma, 5 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 1 CD Formulation, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 11 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 8 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

55 Fillers, Diluents & Binders, 38 Coating Systems & Additives, 28 Disintegrants & Superdisintegrants, 27 Direct Compression, 20 Thickeners and Stabilizers, 19 Taste Masking, 18 Chewable & Orodispersible Aids, 17 Controlled & Modified Release, 16 Granulation, 13 Parenteral, 13 Co-Processed Excipients, 10 Lubricants & Glidants, 9 Film Formers & Plasticizers, 8 API Stability Enhancers, 6 Solubilizers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Emulsifying Agents, 3 Topical, 3 Rheology Modifiers, 2 Coloring Agents

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 36 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 12 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

14 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 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
31/03/2026	Veranova	U.S.A	VERANOVA LP	5038	FENTANYL CITRATE (BULK)	1983-08-15	Active	II	N/A
31/03/2026	Curia	U.S.A	CURIA WISCONSIN INC	18178	FENTANYL CITRATE	2005-03-14	Active	II	Complete	2015-02-24	2014-02-05

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Oralet

Oralet

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

38 API Suppliers

13 USDMF

11 CEP/COS

4 JDMF

2 EU WC

4 KDMF

14 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

552 FDF Dossiers

77 FDA Orange Book

431 Europe

13 Canada

3 South Africa

28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE

TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

18 SPI Pharma

2 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

2 Pfanstiehl

5 Kirsch Pharma

5 Dr. Paul Lohmann GmbH & Co. KGaA

1 ACG Worldwide

6 Actylis

1 Alcedo Pharmachem

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 BASF

1 CD Formulation

10 Corel Pharma Chem

4 DFE Pharma

1 Finar

5 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

4 Ideal Cures

5 Ingredion Pharma Solutions

11 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Neelkanth MineChem

2 Nitika Pharmaceutical Specialities

2 Novo Excipients

2 Pharmatrans-Sanaq

4 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons