Akamin

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 15 USDMF, 7 CEP/COS, 3 JDMF, 2 KDMF, 12 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

75 Drugs in Development

75 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

181 FDF Dossiers, 138 FDA Orange Book, 5 Europe, 7 Canada, 4 Australia, 6 South Africa, 21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 100MG BASE/VIAL, CAPSULE;ORAL - EQ 100MG BASE, CAPSULE;ORAL - EQ 50MG BASE, CAPSULE;ORAL - EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER, EXTENDED RELEASE;DENTAL - EQ 1MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 SPI Pharma, 10 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 3 Kirsch Pharma, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 27 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 10 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 23 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

59 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 29 Direct Compression, 29 Thickeners and Stabilizers, 28 Granulation, 27 Lubricants & Glidants, 24 Solubilizers, 24 Controlled & Modified Release, 19 Film Formers & Plasticizers, 19 Disintegrants & Superdisintegrants, 19 Topical, 13 Parenteral, 13 Co-Processed Excipients, 10 Taste Masking, 9 Empty Capsules, 9 Emulsifying Agents, 8 Chewable & Orodispersible Aids, 6 Surfactant & Foaming Agents, 6 API Stability Enhancers, 6 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 74 News #PharmaBuzz

GLOBAL SALES INFORMATION

21 US Medicaid Prescriptions, 21 Regulatory FDF Prices, 4 Annual Reports

MARKET PLACE

34 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

87 US Patents, 1 US Exclusivities, 1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 50649 / DOSAGE - CAPSULE;ORAL - EQ 100MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINOCYCLINE HYDROCHLORIDE(UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO)	MINOCYCLINE	100mg \| 50mg

Inactive Ingredients

Ingredient Name	Clinical Solutions Wholesale	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	REMEDYREPACK INC.	Unit Dose Services	REMEDYREPACK INC.	Avera McKennan Hospital	Teva Pharmaceuticals USA, Inc.	NuCare Pharmaceuticals, Inc.	A-S Medication Solutions	American Health Packaging	AvPAK	Bryant Ranch Prepack	Denton Pharma, Inc. dba Northwind Pharmaceuticals	Impax Generics	Lake Erie Medical DBA Quality Care Products LLC	NuCare Pharmaceuticals,Inc.	Preferred Pharmaceuticals Inc.	Onset Dermatologics LLC	Alvogen, Inc.	AvKARE, Inc.	Clinical Solutions Wholesale, LLC	KAISER FOUNDATION HOSPITALS	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	Torrent Pharmaceuticals Limited
ALCOHOL(3K9958V90M)
ALUMINUM OXIDE(LMI26O6933)
AMMONIA(5138Q19F1X)
BUTYL ALCOHOL(8PJ61P6TS3)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
D&C RED NO. 28(767IP0Y5NH)
D&C RED NO. 33(9DBA0SBB0L)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
ISOPROPYL ALCOHOL(ND2M416302)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 39aee369 B5dc 4ff4 98de 06fb4189c733 Applno 50649 Form Capsule Oral Dosage Eq 100mg Base - Drug Product Composition: Akamin

Akamin

Akamin

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers

15 USDMF

7 CEP/COS

3 JDMF

2 KDMF

12 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

75 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

181 FDF Dossiers

138 FDA Orange Book

5 Europe

7 Canada

4 Australia

6 South Africa

21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 100MG BASE/VIAL

CAPSULE;ORAL - EQ 100MG BASE

CAPSULE;ORAL - EQ 50MG BASE

CAPSULE;ORAL - EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

POWDER, EXTENDED RELEASE;DENTAL - EQ 1MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

TABLET, EXTENDED RELEASE;ORAL - EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

TABLET, EXTENDED RELEASE;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

5 SPI Pharma

10 DKSH

4 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

3 Kirsch Pharma

4 ACG Worldwide

5 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

27 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

2 Finar

10 Gangwal Chemicals

4 Ideal Cures

3 Ingredion Pharma Solutions

23 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

14 Microlex e.U

1 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

19 Roquette

CAPSULE;ORAL - EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 105MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 135MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

TABLET, EXTENDED RELEASE;ORAL - EQ 55MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 65MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

TABLET, EXTENDED RELEASE;ORAL - EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons