Tox21_300584

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ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 27 USDMF, 10 CEP/COS, 7 JDMF, 10 EU WC, 28 KDMF, 14 NDC API, 15 Listed Suppliers

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

184 FDF Dossiers, 77 FDA Orange Book, 58 Europe, 15 Canada, 2 South Africa, 32 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 15MG BASE, TABLET;ORAL - EQ 30MG BASE, TABLET;ORAL - EQ 45MG BASE, TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG;EQ 15MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE, TABLET;ORAL - EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 12.5MG BASE;EQ 30MG BASE, TABLET;ORAL - EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE;EQ 15MG BASE, TABLET;ORAL - EQ 25MG BASE;EQ 30MG BASE, TABLET;ORAL - EQ 25MG BASE;EQ 45MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 17 SPI Pharma, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Kirsch Pharma, 1 Cerata Pharmaceuticals LLP, 1 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 27 BASF, 1 CD Formulation, 2 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Gloria Interchem, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 22 Kerry, 4 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 5 Prachin Pharmachem, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 20 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders, 48 Coating Systems & Additives, 32 Disintegrants & Superdisintegrants, 32 Direct Compression, 29 Granulation, 29 Solubilizers, 27 Thickeners and Stabilizers, 26 Controlled & Modified Release, 21 Topical, 19 Lubricants & Glidants, 18 Taste Masking, 18 Chewable & Orodispersible Aids, 18 Parenteral, 17 Film Formers & Plasticizers, 17 Co-Processed Excipients, 9 Emulsifying Agents, 7 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 2 Coloring Agents

DIGITAL CONTENT

17 News #PharmaBuzz

17 News #PharmaBuzz

GLOBAL SALES INFORMATION

22 US Medicaid Prescriptions, 6 Regulatory FDF Prices

MARKET PLACE

12 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

24 US Patents, 24 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 6 JP, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

Xls

Filters

Xls

USFDA APPLICATION NUMBER - 22426 / DOSAGE - TABLET;ORAL - EQ 12.5MG BASE;EQ 30MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alogliptin Benzoate(UNII: EEN99869SC) (Alogliptin - UNII:JHC049LO86)	Alogliptin	12.5mg \| 25mg \| 25mg \| 25mg
Pioglitazone hydrochloride(UNII: JQT35NPK6C) (Pioglitazone - UNII:X4OV71U42S)	Pioglitazone	30mg \| 15mg \| 45mg \| 30mg

Inactive Ingredients

Ingredient Name	Padagis Israel Pharmaceuticals Ltd
Alcohol(3K9958V90M)
Butyl Alcohol(8PJ61P6TS3)
Carnauba wax(R12CBM0EIZ)
Croscarmellose sodium(M28OL1HH48)
Ferric oxide Red(1K09F3G675)
Ferric oxide yellow(EX438O2MRT)
Ferrosoferric oxide(XM0M87F357)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
Hypromellose 2910 (6 MPA.S)(0WZ8WG20P6)
Lactose Monohydrate(EWQ57Q8I5X)
Magnesium stearate(70097M6I30)
Mannitol(3OWL53L36A)
Microcrystalline Cellulose(OP1R32D61U)
Polyethylene Glycol 8000(Q662QK8M3B)
Polyglyceryl-10 oleate(55C81W76DH)
Shellac(46N107B71O)
Talc(7SEV7J4R1U)
Titanium dioxide(15FIX9V2JP)

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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.

Setid 642b1e90 701e 42f2 Bac6 A4918738e2c9 Applno 22426 Form Tablet Oral Dosage Eq 12 5mg Base Eq 30mg Base - Drug Product Composition: Tox21_300584

Tox21_300584

Tox21_300584

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

64 API Suppliers

27 USDMF

10 CEP/COS

7 JDMF

10 EU WC

28 KDMF

14 NDC API

15 Listed Suppliers

DEVELOPMENTS

6 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

184 FDF Dossiers

77 FDA Orange Book

58 Europe

15 Canada

2 South Africa

32 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 15MG BASE

TABLET;ORAL - EQ 30MG BASE

TABLET;ORAL - EQ 45MG BASE

TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 850MG;EQ 15MG BASE

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE

TABLET;ORAL - EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 12.5MG BASE;EQ 30MG BASE

TABLET;ORAL - EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 25MG BASE;EQ 15MG BASE

TABLET;ORAL - EQ 25MG BASE;EQ 30MG BASE

TABLET;ORAL - EQ 25MG BASE;EQ 45MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

17 SPI Pharma

6 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Kirsch Pharma

1 Cerata Pharmaceuticals LLP

1 Dr. Paul Lohmann GmbH & Co. KGaA

1 ACG Worldwide

5 Actylis

1 Aeon Procare

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

1 Avesta Pharma

27 BASF

1 CD Formulation

2 Clariant

10 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

2 Finar

11 Gangwal Chemicals

1 Gloria Interchem

5 Ideal Cures

5 Ingredion Pharma Solutions

22 Kerry

4 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

1 Neelkanth MineChem

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

7 Pluviaendo

5 Prachin Pharmachem

TABLET;ORAL - 500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 12.5MG BASE;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 12.5MG BASE;EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons