Minocycline, Hydrochloride | 50808 | TABLET, EXTENDED RELEASE;ORAL | EQ 105MG BASE

Minocycline Hydrochloride

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ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 16 USDMF, 6 CEP/COS, 3 JDMF, 2 KDMF, 12 NDC API, 10 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

46 Drugs in Development

46 Drugs in Development

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

175 FDF Dossiers, 137 FDA Orange Book, 3 Europe, 7 Canada, 2 Australia, 6 South Africa, 20 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- EQ 50MG BASE, CAPSULE;ORAL - EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER, EXTENDED RELEASE;DENTAL - EQ 1MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 105MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 55MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 65MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 80MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Seqens, 8 DKSH, 2 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 27 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 35 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 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, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

78 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 36 Direct Compression, 30 Controlled & Modified Release, 29 Thickeners and Stabilizers, 28 Lubricants & Glidants, 25 Solubilizers, 24 Disintegrants & Superdisintegrants, 23 Granulation, 20 Film Formers & Plasticizers, 18 Topical, 18 Co-Processed Excipients, 13 Parenteral, 10 Taste Masking, 9 Empty Capsules, 8 Emulsifying Agents, 8 Chewable & Orodispersible Aids, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 69 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 21 Finished Drug Prices, 4 Annual Reports

MARKET PLACE

33 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

82 US Patents, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 50808 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 105MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
minocycline hydrochloride(UNII: 0020414E5U) (minocycline - UNII:FYY3R43WGO)	minocycline	105mg \| 80mg \| 55mg

Inactive Ingredients

Ingredient Name	Bryant Ranch Prepack	Teva Pharmaceuticals USA, Inc.	Mylan Pharmaceuticals Inc.	Oceanside Pharmaceuticals	Dr. Reddys Laboratories Inc	NorthStar Rx LLC
ALUMINUM OXIDE(LMI26O6933)
AMMONIA(5138Q19F1X)
CARNAUBA WAX(R12CBM0EIZ)
Cellulose, Microcrystalline(OP1R32D61U)
D&C RED NO. 27(2LRS185U6K)
D&C YELLOW NO. 10(35SW5USQ3G)
Ethylcellulose (10 Mpa.S)(3DYK7UYZ62)
FD&C Blue No. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C Red No. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
Hydroxypropyl Cellulose (Type H)(RFW2ET671P)
HYPROMELLOSE 2208 (4000 MPA.S)(39J80LT57T)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (4000 MPA.S)(RN3152OP35)
Hypromellose 2910 (5 Mpa.S)(R75537T0T4)
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
Isopropyl Alcohol(ND2M416302)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
Polyethylene Glycol 400(B697894SGQ)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
Sodium Stearyl Fumarate(7CV7WJK4UI)
Talc(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
Triethyl Citrate(8Z96QXD6UM)
Water(059QF0KO0R)

Drug Product Composition: Minocycline, Hydrochloride