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ACTIVE PHARMA INGREDIENTS

139 API Suppliers, 36 USDMF, 25 CEP/COS, 7 JDMF, 18 EU WC, 62 KDMF, 19 NDC API, 43 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

810 FDF Dossiers, 83 FDA Orange Book, 417 Europe, 34 Canada, 57 Australia, 67 South Africa, 152 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;37.5MG, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 150MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 6 Evonik, 2 Rochem International Inc, 18 SPI Pharma, 12 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 11 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 7 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 1 Avesta Pharma, 34 BASF, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 22 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

98 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 47 Disintegrants & Superdisintegrants, 40 Thickeners and Stabilizers, 40 Controlled & Modified Release, 39 Direct Compression, 36 Solubilizers, 33 Granulation, 28 Lubricants & Glidants, 27 Topical, 23 Film Formers & Plasticizers, 21 Parenteral, 20 Taste Masking, 19 Chewable & Orodispersible Aids, 19 Co-Processed Excipients, 11 Emulsifying Agents, 9 Rheology Modifiers, 9 Empty Capsules, 8 API Stability Enhancers, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 63 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 387 Regulatory FDF Prices

MARKET PLACE

60 APIs, 27 FDF Dossiers

PATENTS & EXCLUSIVITIES

9 US Patents, 12 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 8 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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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
25/04/2025	Supriya Lifescience	India	SUPRIYA LIFESCIENCE LTD	39533	TRAMADOL HYDROCHLORIDE USP	2024-02-29	Active	II	N/A
25/04/2025	Seqens	France	WAVELENGTH ENTERPRISES LTD	11959	TRAMADOL HYDROCHLORIDE	1996-05-06	Active	II	Complete	2013-01-30	2013-01-08

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

139 API Suppliers

36 USDMF

25 CEP/COS

7 JDMF

18 EU WC

62 KDMF

19 NDC API

43 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

810 FDF Dossiers

83 FDA Orange Book

417 Europe

34 Canada

57 Australia

67 South Africa

152 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 325MG;37.5MG

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 100MG

CAPSULE, EXTENDED RELEASE;ORAL - 150MG

CAPSULE, EXTENDED RELEASE;ORAL - 200MG

CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

1 Minakem

6 Evonik

2 Rochem International Inc

18 SPI Pharma

12 DKSH

1 Pharm-RX Chemical

7 Faran Shimi Pharmaceutical

11 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

7 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Pramukh Pharmachem

1 Zeal MediPharma

4 ACG Worldwide

5 Actylis

1 Aeon Procare

3 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

1 Avesta Pharma

34 BASF

3 Clariant

11 Corel Pharma Chem

7 DFE Pharma

2 Finar

12 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

4 Kima Chemical

6 Lonza Capsugel

17 Microlex e.U

1 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

4 Novo Excipients

TABLET;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons