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Amlodipine Besylate

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ACTIVE PHARMA INGREDIENTS

112 API Suppliers, 41 USDMF, 43 CEP/COS, 25 JDMF, 27 EU WC, 92 KDMF, 26 NDC API, 54 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

763 FDF Dossiers, 424 FDA Orange Book, 47 Europe, 134 Canada, 34 South Africa, 124 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE, TABLET;ORAL - EQ 5MG BASE, CAPSULE;ORAL - EQ 10MG BASE;20MG, CAPSULE;ORAL - EQ 10MG BASE;40MG, CAPSULE;ORAL - EQ 2.5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;20MG, CAPSULE;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;14MG, TABLET;ORAL - EQ 2.5MG BASE;3.5MG, TABLET;ORAL - EQ 5MG BASE;7MG, TABLET;ORAL - EQ 10MG BASE;200MG, TABLET;ORAL - EQ 2.5MG BASE;200MG, TABLET;ORAL - EQ 5MG BASE;200MG, TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 10MG BASE;160MG, TABLET;ORAL - EQ 10MG BASE;320MG, TABLET;ORAL - EQ 5MG BASE;160MG, TABLET;ORAL - EQ 5MG BASE;320MG, TABLET;ORAL - EQ 10MG BASE;20MG, TABLET;ORAL - EQ 10MG BASE;40MG, TABLET;ORAL - EQ 5MG BASE;20MG, TABLET;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;320MG, TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 5MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Rochem International Inc, 21 SPI Pharma, 2 Seqens, 19 DKSH, 3 Jai Radhe Sales, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 3 Alcedo Pharmachem, 12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 35 BASF, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

113 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 55 Direct Compression, 48 Disintegrants & Superdisintegrants, 43 Thickeners and Stabilizers, 38 Solubilizers, 35 Controlled & Modified Release, 33 Lubricants & Glidants, 32 Granulation, 27 Topical, 24 Parenteral, 24 Film Formers & Plasticizers, 22 Co-Processed Excipients, 21 Chewable & Orodispersible Aids, 19 Taste Masking, 13 Emulsifying Agents, 10 Rheology Modifiers, 10 API Stability Enhancers, 9 Empty Capsules, 8 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 40 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 40 Finished Drug Prices, 1 Annual Reports

MARKET PLACE

35 APIs, 7 FDF Dossiers

PATENTS & EXCLUSIVITIES

33 US Patents, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 1 USP, 7 JP, 1 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	16473	AMLODIPINE BESILATE USP	2003-03-19	Active	II	Complete	2013-05-21	2013-05-10
28/10/2024	Moehs Iberica	Spain	MOEHS IBERICA SL	17070	AMLODIPINE BESILATE	2003-12-29	Active	II	N/A

Amlodipine Besylate

Amlodipine Besylate

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

112 API Suppliers

41 USDMF

43 CEP/COS

25 JDMF

27 EU WC

92 KDMF

26 NDC API

54 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

763 FDF Dossiers

424 FDA Orange Book

47 Europe

134 Canada

34 South Africa

124 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 2.5MG BASE

TABLET;ORAL - EQ 5MG BASE

CAPSULE;ORAL - EQ 10MG BASE;20MG

CAPSULE;ORAL - EQ 10MG BASE;40MG

CAPSULE;ORAL - EQ 2.5MG BASE;10MG

CAPSULE;ORAL - EQ 5MG BASE;10MG

CAPSULE;ORAL - EQ 5MG BASE;20MG

CAPSULE;ORAL - EQ 5MG BASE;40MG

TABLET;ORAL - EQ 10MG BASE;14MG

TABLET;ORAL - EQ 2.5MG BASE;3.5MG

TABLET;ORAL - EQ 5MG BASE;7MG

TABLET;ORAL - EQ 10MG BASE;200MG

TABLET;ORAL - EQ 2.5MG BASE;200MG

TABLET;ORAL - EQ 5MG BASE;200MG

TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE

TABLET;ORAL - EQ 10MG BASE;160MG

TABLET;ORAL - EQ 10MG BASE;320MG

TABLET;ORAL - EQ 5MG BASE;160MG

TABLET;ORAL - EQ 5MG BASE;320MG

TABLET;ORAL - EQ 10MG BASE;20MG

TABLET;ORAL - EQ 10MG BASE;40MG

TABLET;ORAL - EQ 5MG BASE;20MG

TABLET;ORAL - EQ 5MG BASE;40MG

TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG

TABLET;ORAL - EQ 10MG BASE;25MG;160MG

TABLET;ORAL - EQ 10MG BASE;25MG;320MG

TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG

TABLET;ORAL - EQ 5MG BASE;25MG;160MG

TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

3 Rochem International Inc

21 SPI Pharma

2 Seqens

19 DKSH

3 Jai Radhe Sales

1 Pharm-RX Chemical

8 Faran Shimi Pharmaceutical

TABLET;ORAL - EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons