Generic API Product List

APIs

Dabigatran Etexilate Mesylate * Anticoagulant

Product	USDMF	CEP	EDMF	China DMF	CADIFA Brazil	KDMF	Russia	ANVISA BRAZIL	Therapeutic Use
Aripiprazole	√	√		√		√			Antipsychotic/Antidepressant
Articaine HCl		√				√	√		Anesthetic
Atomoxetine HCl	√	√		√	√		√	**	Attention Deficit Hyperactivity Disorder (ADHD)
Baclofen	*	√	√	*		√	√		Skeletal Muscle Relaxant
Benserazide		√				√			Anti-Parkinson
Betahistine DiHCl		√		√	√	*	√	*	Anti-Vertigo
Buspirone	√	√							Anti-anxiety
Calcium Acetate	√								Phosphate-removing Agent
Cilostazol	*								Antiplatelet
Dabigatran Etexilate Mesylate		*							Anticoagulant
Dapagliflozin propanediol monohydrate	*	*	*			√		*	Antidiabetic
Desvenlafaxine	*								Antidepressant
Dexmethylphenidate HCl									Attention Deficit Hyperactivity Disorder (ADHD)

Diflunisal	√			√					NSAID
Dipyridamole	√	√			√		√		AntiPlatelet
Doxazosin Mesylate	√	√	√		√		√		Antihypertensive
Drotaverine HCl			√	√			√		AntiSpasmodic
Entacapone	√	√		√	√	√	√		AntiParkinson
Fenoprofen	√								NSAID
Flurbiprofen		√				√	√		NSAID
Fluvoxamine Maleate	√	√		√			√	*	Antidepressant
Glycopyrrolate	√					√			Anticholinergic Agent
Hydralazine HCl	√			*					Antihypertensive
Hydroxyzine Pamoate	*								Antihistamine
Irinotecan HCl Trihydrate	*	√							Oncology
Isosulfan Blue	√								Diagnostic Dye
L-Carglumic Acid	√								Ammonia Detoxicants
Lamotrigine	*	√		√	√	√	√	√	Antiepileptic
Levodropropizine		√				√			Antitussive, Cough suppressant
Levomepromazine Maleate		√	√						Antipsychotic
Lercanidipine		*							Antihypertensive
Lisdexamfetamine dimesylate	*							*	ADHD
Lurasidone HCl	*								Antipsychotic
Malathion									Cholinesterase Inhibitors
Maraviroc	√								Antiarrhythmic
Mebeverine HCl		√	√	√			√	√	AntiSpasmodic
Methylene Blue									Oxidation-Reduction Agent
MethylphenidateHCl		√		√	*			√	Attention Deficit Hyperactivity Disorder (ADHD)
Metyrosine	√				*				Catecholamine Synthesis Inhibitor
Midazolam	√	√	√		√	√	√	√	Anesthetic
Nitazoxanide	√								Anti-Infective
Oxolamine Citrate									Cough suppressant
Oxolamine Phosphate									Cough suppressant
Oxymetazoline		*							Decongestant, Vasoconstrictor
Pinavarium bromide	**								Antispasmodic
Pirfenidone	√	√		√	√	√			AntiInflammatory, Antifibrotic
Posaconazole	√								Antifungal
Probenecid	√								Uricosuric Agents
Pyridostigmine	*	*							Cholenesterase Inhibitor
Quetiapine Fumarate	√	√		√	√	√	√	√	Antipsychotic
Ractopamine HCl	*				√			*	Animal Feed Additive
Rivaroxaban	√	√	√	√	√	√	√	*	Anticoagulant
Sulfasalazine	*								Anti-Inflammatory
Tamsulosin HCl	√	√		√	√	√	√	√	Benign Prostatic Hyperplasia
Tapentadol Phosphate			*						Analgesic
TapentadolHCl		*							Analgesic
Trientine	√								Copper Chelating Agent
Trimebutine		*				√			Antispasmodic
Trimetazidine dihydrochloride		*						**	Antianginal
Venlafaxine HCl	*	√		*	*				Antidepressant
Zilpaterol									Veterinary
Zonisamide	*		√	√		√			Anticonvulsant

Product	Therapeutic Use	Status
Apixaban	Anticoagulant	Under Validation
Acotiamide	Anti-Dyspepsia	Under Validation
Dexlansoprazole	Proto Pump Inhibitors	Lab Validation
Edoxaban	Anticogulant	Under Validation
Erdosteine	Mucolytic Agent	Under Validation
Hydroxyzine Pamoate	Antihistamine	Validation Completed
Indapamide	Antihypertensive	Under Validation
Lercanidipine	Antidepressant, Anxiolytic	Validation Completed
Loxoprofen	Non-Steroidal Anti-Inflammatory	Validation Completed

Pellets

Product Name	DMF/Tech Pack	Bio equivalence established (Y/N)	Type of BE study Fast/Fed	RLD/Mkt	Stability	Brazil	Turkey	Mexico	MENA	APAC
Duloxetine HCl Delayed Release Pellets 20% (HPMC Acetyl Succinate)	DMF	Yes	Fast & Fed	CYMBALTA / EU	Available 36 M	Yes	Yes	Yes	Yes	Yes
Duloxetine HCl Delayed Release Pellets 20% (HPMC Phthalate)	DMF/Tech Park	Yes	Fasting & Fed	CYMBALTA / Turkey/ EU	Available 36 M	No	No	No	No	Yes
Duloxetine Delayed Release Pellets 17% (HPMC Phthalate)	DMF/Tech Park	No	No	–	Available 12 M	Yes	No	No	Yes	Yes
Itraconazole Immediate Release Pellets 21.74%	DMF	Yes	Fasting & Fed	SPORANOX / US	Available 36 M	No	No	Yes	No	Yes
Itraconazole Immediate Release Pellets 22%	DMF	No	No	–	Available 36 M	Yes	No	Yes	Yes	Yes
Venlafaxine HCl Extended Release Pellets 33%	Dossier/DMF	Yes	Fasting & Fed	EFFEXOR / EU	Available 36 M	Yes	Yes	Yes	Yes	Yes
Omeprazole Delayed Release Pellets 8.5% (LD-30)	Dossier/DMF	No		No	Available 36 M	No	No	Yes	Yes	Yes
Omeprazole Delayed Release Pellets 8.5% (Phthalate)	Dossier/DMF	Yes	Fast & Fed	Customer Established BE in Indonesia	Available 36 M	No	No	Yes	Yes	Yes

Product Name	DMF/ Tech Pack	Bioequivalence Established	Type of BE Study	RLD/Mkt	Stability	Brazil	Turkey	Mexico	MENA	APAC
Duloxetine Hydrochloride Delayed Release Pellets 17%	Tech Pack	No	No	No	6M data available	–	–	–	–	–
Trimetazidine Extended Release Pellets 55%	Tech Pack	No	No	VASTAREL MR/ Brazil	6M data available	Yes	–	–	–	–
Dabigatran Etexilate Pellets 35%	Tech Pack	No	Fast Single Dose Study	PRADAXA/ US	3M data available	–	–	–	Yes	–

Finished Dosage Forms

Product	Strength	ANDA (Approved/Filed)	EU Dossier (Approved/Filed)	ANDS (Approved/Filed)	Countries for which Dossier are available
Baclofen Tablets	5mg	Approved	Not Filed		Except USA
Baclofen Tablets	10mg	Approved	Not Filed		Except USA
Baclofen Tablets	20mg	Approved	Not Filed		Except USA
Cinacalcet tablets	30 mg	Approved	Approved		Can be offered globally
Cinacalcet tablets	60 mg	Approved	Approved		Can be offered globally
Cinacalcet tablets	90 mg	Approved	Approved		Can be offered globally
Doxazosin tablets	1 mg	Filed	Not filed	Approved in CA	Except USA, Canada
Doxazosin tablets	2 mg	Filed	Not filed	Approved in CA	Except USA, Canada

Product	Strength	Status
FERRIC CITRATE Tablets	EQ210 IRON	Proof of concept established
Aspirin+Dipyridamole ER Capsules	25/200mg	Proof of concept established
Mexiletine Capsules	150mg/200mg/250mg	Proof of concept established
Diflunisal tablets	500 mg	Proof of concept established
Dipyridamole ER capsules	200 mg	Proof of concept established
Solifenacin & Tamsulosin PR tablets	6 mg/0.4 mg	Proof of concept established
Hydralazine HCl tablets	10 mg, 25 mg, 50 mg and 100 mg	Proof of concept established
Tamsulosin MR tablets	0.4mg	Under development

Nintedanib Esylate	AniInflammatory, Antifibrotic	Lab Validation
Propafenone	Antiarrhythmic agents	Validation Completed
Pyridostigmine Bromide	Cholinesterase Inhibitor	Validation Completed
Remimazolam Besylate (Intermediate)	Sedative, General Anesthetic	Validation Completed
Safinamide	Anti-Parkinson	Under Validation

Levodopa & Benserazide IR granules (for encapsulation)	Under development	June’24	Fast	Madopar Capsules
Levodopa & Benserazide IR granules (Direct compressable)	Under development	June’24	Fast	Madopar Tablets
Desvenlafaxine succinate SR Pellets 41.38%	to be initiated			PRISTIQ Tablets
Propiverine MR Pellets	to be initiated			Detrunorm MR capsules

Methylphenidate HCl ER Capsules	10 mg ,20 mg , 30 mg and 40 mg	Under development
Dabigatran etexilate Capsules	75 mg, 110 mg, 150 mg	Under development
Dexlansoprazole DR capsules	30 mg and 60 mg	Under development
Trimetazidine MR Tablets	35 mg	Under development
Hydralazine HCl + Isosorbide Dinitrate tablets	37.5mg/20mg	Under development
Galantamine ER Capsules	8mg/16mg/24mg	Under development
Levodopa + Benserazide Dispersible Tablets	50mg + 12.5mg, 100mg +25mg	Under development
Levodopa + Benserazide IR Capsules	50mg + 12.5mg, 100mg + 25mg, 200mg + 50mg	Under development
Levodopa + Benserazide IR Tablets	50mg + 12.5mg, 100mg + 25mg, 200mg + 50mg	Under development
Levodopa + Benserazide PR Capsules	100mg + 25mg, 200mg + 50mg	Under development
Levodopa + Benserazide ER Tablets	200mg + 50mg	To be initiated
Trimetazidine IR Tablets	20 mg	To be initiated
Nafronyl MR Tabs	100 mg	To be initiated
Aripiprazole ODT	2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg	To be initiated
Betahistine tablets	8mg, 16mg, 24mg	To be initiated
Fluvoxamine Maleate Tablets	25 mg, 50 mg, 100 mg	To be initiated
Fluvoxamine Maleate ER Capsules	100 mg, 150 mg	To be initiated
Lamotrigine Dispersible /Chewable tabs	2mg, 5mg, 25mg,100mg	To be initiated
Bempedoic Acid Tablets	180mg	To be initiated
Lisdexamfetamine dimesylate Capsules	10mg, 20mg, 30mg, 40mg, 50mg, 60mg, 70mg	To be initiated

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