Out Licensing - Alkaloid

PRODUCT DOSSIERS AND MARKETING AUTHORIZATIONS IN EU COUNTRIES

AVAILABLE DOSSIERS AND MAs

GENERIC NAME (click to open)	PHARMACEUTICAL FORM & STRENGTH	PHARMACO THERAPEUTIC GROUP	TYPE OF APPLICATION	MAs AVAILABLE IN
SOLIDS
ALPRAZOLAM	tablets 0.25 mg; 0.5 mg; 1 mg	anxiolytic	generic	HU
AMLODIPINE/ ATORVASTATIN	film-coated tablets 5 mg/10 mg; 10 mg/10 mg	antihypertensive/ hypolipidemic	generic	RO*
ANTACID (CaCO 3 +MgCO 3 )	chewable tablets 680 mg/80 mg	antacid	hybrid	BE, CZ, DE, HU, NL,PT, SK, UK
ATORVASTATIN	film-coated tablets 10 mg; 20 mg; 40 mg; 80 mg	hypolipidemic	generic	RO, SK, UK
BISOPROLOL	film-coated tablets 2.5 mg film-coated tablets 5 mg; 10 mg	antihypertensive/ antianginal/medicine for treatment of heart failure	generic	RO, SK HU, RO, SK
CARBOCISTEINE	capsules, hard 375 mg	mucolytic	generic	N/A
CEFADROXIL	capsules, hard 500 mg	antibiotic	generic	N/A
CEFIXIME	film-coated tablets 400 mg	antibiotic	generic	PT, UK
COLD & FLU (PARACETAMOL/ PSEUDOEPHEDRINE/ DEXTROMETHORPHAN/ ASCORBIC ACID)	film-coated tablets 500 mg/30 mg/ 15 mg/60 mg	analgesic/ antipyretic/ decongestant/ vitamin C	bibliographic	N/A
FLECAINIDE	tablets 50 mg; 100 mg	antiarrhythmic	generic	NL
IBUPROFEN LYSINE	film-coated tablets 342 mg	analgesic/ antipyretic	generic	NL, SK, UK
IBUPROFEN LYSINE	film-coated tablets 684 mg	analgesic/ antipyretic	generic	CZ, DE, SK, UK
IBUPROFEN/ PARACETAMOL	film-coated tablets 200 mg/500 mg	analgesic/ antipyretic	generic	DK, EL, HU, MT
LISINOPRIL/ AMLODIPINE	tablets 10 mg/5 mg; 20 mg/5 mg; 20 mg/10 mg	antihypertensive	generic	MT
LISINOPRIL/ HYDROCHLOROTHIAZIDE	tablets 20 mg/12.5 mg	antihypertensive	generic §	CZ, HU, RO
METFORMIN	film-coated tablets 500 mg; 850 mg; 1000 mg	antidiabetic	generic	N/A
MOXIFLOXACIN	film-coated tablets 400 mg	antibiotic	generic	N/A
ROSUVASTATIN	film-coated tablets 5 mg; 10 mg; 20 mg; 40 mg	hypolipidemic	generic	DK, HU, UK
ZOLPIDEM	film-coated tablets 5 mg; 10 mg	hypnotic/ sedative	generic §	RO, UK

GENERIC NAME	PHARMACEUTICAL FORM & STRENGTH	PHARMACO THERAPEUTIC GROUP	TYPE OF APPLICATION	MAs AVAILABLE IN
LIQUIDS
CEFADROXIL	granules for oral suspension 250 mg/5 ml	antibiotic	generic	N/A
CEFIXIME	granules for oral suspension 100 mg/5 ml	antibiotic	generic	HU, PT
IBUPROFEN	oral suspension 100 mg/5 ml	analgesic/ antipyretic	generic	UK
IBUPROFEN	oral suspension 200 mg/5 ml	analgesic/ antipyretic	generic	CZ, DE
LEVOMETHADONE	oral solution 5 mg/ml	opioid analgesic	generic	DE*, HU, RO, IT
METHADONE	concentrate for oral solution 10 mg/ml	substitute for opioid dependence	bibliographic	CZ, DE, PT, RO, UK, SK
METHADONE	oral solution 1 mg/ml	substitute for opioid dependence	bibliographic	IE, MT, UK

GENERIC NAME	PHARMACEUTICAL FORM & STRENGTH	PHARMACO THERAPEUTIC GROUP	TYPE OF APPLICATION	MAs AVAILABLE IN
SEMI-SOLIDS
DICLOFENAC DIETHYLAMINE	topical gel 1.16 %; 2.32 %	analgesic	hybird	CZ, DE, GR, IT,MT, RO, SK*
DIMETINDENE MALEATE	topical gel 0.1 %	antipruritic/ antihistamine	hybrid	DE, IT, RO*
IBUPROFEN	gel 50 mg/g	analgesic	hybrid	DE,RO,CZ, SK,HU, PT, IT*

GENERIC NAME	PHARMACEUTICAL FORM & STRENGTH	PHARMACO THERAPEUTIC GROUP	TYPE OF APPLICATION	DEVELOPMENT TIMELINE
SOLIDS
ANTACID TRIPLE (SODIUM ALGINATE/ SODIUM BICARBONATE/ CALCIUM CARBONATE)	chewable tablets 250 mg/ 133.5 mg/80 mg	antacid	hybrid	In early development
METAMIZOLE SODIUM	film-coated tablets 500 mg	analgesic/ antipyretic	generic	Q4 2024
METFORMIN	prolonged-release tablets 500 mg; 750 mg; 1000 mg	antidiabetic	generic	In development
PERINDOPRIL ARGININE	film-coated tablets 2.5 mg; 5 mg; 10 mg	angiotensin- converting enzyme (ACE) inhibitor	generic	In early development
RAMIPRIL	film-coated tablets 1.25 mg; 2.5 mg; 5 mg; 10 mg	antihypertensive	generic	Q3 2025
SITAGLIPTIN	film-coated tablets 25 mg; 50 mg; 100 mg	antidiabetic (DPP-4 inhibitor)	generic	Q4 2023
SITAGLIPTIN / METFORMIN	film-coated tablets 50 mg/1000 mg; 50 mg/850 mg	antidiabetic	generic	In development
TADALAFIL	orodispersible tablets 5 mg; 10 mg; 20 mg	erectile dysfunction	generic	In early development

GENERIC NAME	PHARMACEUTICAL FORM & STRENGTH	PHARMACO THERAPEUTIC GROUP	TYPE OF APPLICATION	DEVELOPMENT TIMELINE
LIQUIDS
ANTACID ORAL (SODIUM ALGINATE/ POTASSIUM BICARBONATE)	oral suspension 500 mg/5 ml + 100 mg/5 ml	antacid	hybrid	In early development

GENERIC NAME	PHARMACEUTICAL FORM & STRENGTH	PHARMACO THERAPEUTIC GROUP	TYPE OF APPLICATION	DEVELOPMENT TIMELINE
SEMI-SOLIDS
CLOTRIMAZOLE	topical cream 10 mg/g	antifungals for topical use	bibliographic	In development
MUPIROCIN	ointment 20 mg/g	antibiotic for topical use	hybrid	Q4 2025

Business development contact info:

+ 389 2 3110 745, + 389 2 3110 749

business.development@alkaloid.com.mk

ALKALOID’S PRODUCT LIST WITH STABILITY DATA AVAILABLE FOR CLIMATE ZONE IVB (30°C/75% RH)

GENERIC NAME (click to open)	PHARMACEUTICAL FORM & STRENGTH	PRIMARY PACKAGING	PHARMACO THERAPEUTIC GROUP	STABILITY DATA AVAILABLE
ACICLOVIR	30 mg/g eye ointment	Aluminium tube	antiviral	24 months
ALPRAZOLAM	tablets 0.25 mg; 0.5 mg; 1 mg	PVC/PVdC/ Al foil	anxiolytic	36 months
ANTACID (CaCO 3 /MgCO 3 )	chewable tablets 680 mg/80 mg	Alu/Al foil	antacid	36 months
CARBOCISTEINE	capsules, hard 375 mg	Alu/Al foil	mucolytic	48 months
CEFIXIME	film-coated tablets 400 mg	Alu/Al foil	antibiotic	24 months
CHLORAMPHENICOL	10 mg/g eye ointment	Aluminium tube	antibiotic	36 months
DICLOFENAC	1.16% gel	Aluminium tube	analgesic	24 months
DICLOFENAC	2.32% gel	Aluminium tube	analgesic	24 months
DIMETINDENE	1 mg/g gel	Aluminium tube	antihistamine	24 months
FLECAINIDE	tablets 50 mg; 100 mg	PVC/PVdC/Al foil	antiarrhythmic	48 months
IBUPROFEN	oral suspension 200 mg/5 mL	Brown neutral glass bottle	analgesic/ antipyretic	24 months
IBUPROFEN LYSINE	film-coated tablets 342 mg	AquaBa/Al foil	analgesic/ antipyretic	24 months
IBUPROFEN LYSINE	film-coated tablets 684 mg	PVC/PVdC/Al foil	analgesic/ antipyretic	36 months
IBUPROFEN/ PARACETAMOL	film-coated tablets 200 mg/500 mg	PVC/PVdC/Al foil & child-resistant PVC/PVDC/Al foil	analgesic/ antipyretic	48 months
LEVOMETHADONE	oral solution 5 mg/mL	Dark glass bottle	substitute for opioid dependence	36 months
LOSARTAN	film-coated tablets 50 mg, 100 mg	PVC/Al foil	antihypertensive	36 months
LISINOPRIL/ AMLODIPINE	tablets 10 mg/5 mg; 20 mg/5 mg; 20 mg/10 mg	PVC/PVdC/Al foil	antihypertensive	48 months
METFORMIN	film-coated tablets 500 mg; 850 mg; 1000 mg	PVC/Al foil	antidiabetic	48 months
METHADONE	concentrate for oral solution 10 mg/mL	Brown glass bottle	substitute for opioid dependence	48 months
METHADONE	oral solution 1 mg/mL	Brown glass bottle	substitute for opioid dependence	36 months
MOXIFLOXACIN	film-coated tablets 400 mg	Alu/Al foil	antibiotic	36 months
ROSUVASTATIN	film-coated tablets 5 mg; 10 mg; 20 mg; 40 mg	Alu/Al foil	hypolipidemic	36 months
ZOLPIDEM	film-coated tablets 10 mg	PVC/Al foil	hypnotic and sedative	60 months

Business development contact info:

+ 389 2 3110 745, + 389 2 3110 749

business.development@alkaloid.com.mk

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