Generic API Product List

APIs

Product	USDMF	CEP	EDMF	China DMF	CADIFA Brazil	KDMF	Russia	Others	Therapeutic Use
Aripiprazole	√	√	*	*	*	√		* JDMF	Antipsychotic/Antidepressant
Articaine HcI		√	*			√	*		Dental Anesthetic
Atomoxetine HcI	√	√	*	√				TDMF, Canada	Attention Deficit Hyperactivity Disorder (ADHD)
Baclofen	√	√	*	*	*	√	*	* JDMF	Skeletal Muscle Relaxant
Betahistine DiHcl		√	*	√	√				AntiVertigo
Brivudine			√					Depending upon customer interest filing can be done	Antiviral
Dapagliflozin propanediol monohydrate	√			√	√	√			Antidiabetic
Dexmethylphenidate HcI								Tech Pack	Attention Deficit Hyperactivity Disorder (ADHD)

Product	Therapeutic Use	Status
Benserazide	Anti-Parkinsons	Process validation Completed
Lisdexamfetamine dimesylate	Attention deficit Hyperactivity disorder (ADHD) treatment, Antidepressant, Schizophrenia treatment	Process validation Completed
Dabigatran	Antithrombotic	Under process validation
Cilostazol	Antithrombotic, Vasodilator	Process validation Completed
Desvenlafaxine	Antidepressant, Anxiolytic	Development Completed. Process validation to start
Oxymetazoline	Decongestant, Vasoconstrictor	Under process validation
Remimazolam	Local anesthetics, Sedative	Under process validation
Loxoprofen	Analgesic, Anti-inflammatory	Under process validation

Product Name	DMF/Techpack	Bio equivalence established (Y/N)	Type of BE study Fast/Fed	RLD/Mkt	Stability	Brazil	Turkey	Mexico	MENA	APAC
Duloxetine DR Pellets 17% (HPMC Phthalate)	Techpack	No			6M				Yes
Duloxetine HCl DR Pellets 20% (HPMC Acetyl succinate)	DMF	Yes	Fast & Fed	CYMBALTA/EU	36M		Yes	Yes
Duloxetine HCl DR Pellets 20% (HPMC Phthalate)	DMF	Yes	Fast & Fed	CYMBALTA/EU	36M		Yes	Yes
Fenofibrate SR Pellets 75%	DMF	No			36M	Yes			Yes
Fenofibric acid DR Pellets 29%	DMF	No			6M		Yes	Yes
Itraconazole IR Pellets 21.74%	DMF	Yes	Fast & Fed	SPORANOX/US	24M					Yes
Itraconazole IR Pellets 22%	DMF	No			36M	Yes		Yes	Yes
Lansoprazole Pellets 8.5%	DMF	No *		* Customer established BE in TR	36M	Yes			Yes	Yes

Product Name	DMF/ Techpack	Bio equivalence will be available by	Type of BE study Fast/Fed	RLD/Mkt	Stability
Posaconazole DR granules 16.39% (Direct compressable)	DMF	Available	Fast & Fed	Noxafil Capsules/US	6 M
Dabigatran etexilate SR pellets 35% w/w	Tech pack	Feb’23	Fast & Fed	PRADAXA/US	6 M
Dexlansoprazole DR pellets 22.5% w/w	Tech pack	Mar’23	Fast & Fed	DEXILANT/US	3 M
Dipyridamole SR pellets 40% w/w	Tech pack	Available	Fast & Fed	AGGRENOX/US	6 M
Donepezil IR pellets 11.11% w/w	Tech pack	To be done	Fast	NAMZARIC/US	6 M
Esomeprazole DR pellets 22.5% w/w	Tech pack	Available	Fast	NEXIUM/EU	12 M
Memantine SR pellets 14 % w/w	Tech pack	Available	Fast & Fed	NAMZARAC/US	6 M
Methylphenidate HCL MR Pellets 11%	Tech pack	Available	Fast & Fed	Ritalin LA 40mg	6 M

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

Levodropropizine	Antitussive, Cough suppressant	Under process validation
Trimetazidine	Anti-anginal	Under process validation
Irinotecan Hydrochloride	Oncology	Development Completed. Process validation to start
Lenalidomide Form-A	Oncology	Development Completed. Process validation to start
Lenalidomide Form-B	Oncology	Development Completed. Process validation to start
Methotrexate	Oncology	Feasibility stage

Galantamaine SR Pellets 8% w/w	Under development	Mar’23	Fast & Fed	Reminyl/Razadyne 8mg
Trimetazidine ER granules (Direct compressable)	Under development	Mar’23	Fast & Fed	Vastarel MR
Levodopa & Benserazide ER granules (for encapsulation)	Under development	June’24	Fast & Fed	Madopar PR capsules
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