Sr. No.APITherapeutic CategoryRegulatory Status
1EdaravoneAmyotrophic Lateral SclerosisUSDMF
2Esketamine HydrochlorideAnestheticCEP
3Ketamine HydrochlorideAnestheticCEP
4ProchlorperazineAnti EmeticUS DMF
5Prochlorperazine EdisylateAnti EmeticUS DMF
6Prochlorperazine MaleateAnti EmeticUS DMF/CEP
7TavaboroleAnti FungalUS DMF
8TretinoinAntiacneUS DMF/CEP/CDMF
9IsotretinoinAntiacneUSDMF
10IsoproterenolAntiadrenergicUSDMF/CEP
11DofetilideAntiarrhythmicUSDMF
12Mexiletine HClAntiarrhythmicUSDMF/CEP
13Procainamide HClAntiarrhythmicUS DMF/CEP
14ZileutonAntiasthmaticUS DMF
15Montelukast SodiumAntiasthmaticUSDMF/ CEP/ EDMF/ CDMF/ KDMF/ IDL China
16Levofloxacin HemihydrateAntibacterialEDMF
17Moxifloxacin HydrochlorideAntibacterialEDMF
18OfloxacinAntibacterialEDMF
19TigecyclineAntibioticTech Pack
20FosfomycinAntibiotic - Urinary Tract InfectionTech Pack
21MupirocinAntibiotic (Topical)DMF
22Mupirocin CalciumAntibiotic (Topical)Tech Pack
23Silver SulfadiazineAntibiotic (Topical)Tech Pack
24BelinostatAnticancerUS DMF
25Bendamustine HClAnticancerUSDMF / DMF
26BortezomibAnticancerUS DMF
27CarfilzomibAnticancerUS DMF
28ChlorambucilAnticancerUS DMF/CEP
29ClofarabineAnticancerUS DMF
30DecitabineAnticancerUS DMF
31MelphalanAnticancerUSDMF/ CEP/ CDMF
32Melphalan HClAnticancerUS DMF/ CDMF
33NelarabineAnticancerUS DMF
34NilutamideAnticancerUS DMF/CEP
35PalbociclibAnticancerUS DMF
36PlerixaforAnticancerUS DMF
37TemozolamideAnticancerUS DMF/CEP
38Tipiracil HClAnticancerUS DMF
39Gemcitabine HCIAnticancerDMF
40MethotrexateAnticancerDMF
41Pemetrexed Disodium HeptahydrateAnticancerDMF
42GlycopyrolateAnticholinergicTech Pack
43ApixabanAnticoagulantDMF / USDMF / EDMF
44Dabigatran EtexilateAnticoagulantDMF
45Edoxaban TosylateAnticoagulantUSDMF
46BrivaracetamAnticonvulsantDMF
47LacosamideAnticonvulsantCEP
48Mirogabalin besylateAnticonvulsantTech Pack
49BrexpiprazoleAntidepressantUS DMF / Tech Pack
50Clomipramine HClAntidepressantUS DMF/CEP
51Vortioxetine HydrobromideAntidepressantUSDMF, EDMF
52AlogliptinAntidiabeticTech. Pack
53DapagliflozinAntidiabeticTech Pack / DMF
54EmpagliflozinAntidiabeticUSDMF/ EDMF/ TDMF / Tech Pack
55Empagliflozin Amorphous fromAntidiabeticTech Pack
56Ertugliflozin L-PyroglutamateAntidiabeticUSDMF/ EDMF
57SaxagliptinAntidiabeticTech Pack
58Sitagliptin HydochlorideAntidiabeticDMF
59Sitagliptin Phophate MonohydrateAntidiabeticUSDMF/ CEP/ TDMF/ CNDMF/ EDMF
60Teneligliptin HydrobromideAntidiabeticDMF
61VildagliptinAntidiabeticDMF
62LinagliptinAntidiabeticUSDMF / EDMF
63Linagliptin Form CAntidiabeticUSDMF/ EDMF / DMF
64Saxagliptin HydrochlorideAntidiabeticUSDMF/ EDMF/ TDMF
65Saxagliptin Monohydrate / Saxagliptin BaseAntidiabeticTechnical Package
66Sitagliptin Phosphate AnhydrousAntidiabeticUSDMF / EDMF
67CannabidiolAntiepilepticUS DMF
68Fenfluramine HClAntiepilepticUSDMF
69PrimidoneAntiepilepticUS DMF/CEP
70VigabatrinAntiepilepticUS DMF/CEP
71ItraconazoleAntifungalDMF / CEP / USDMF
72LanoconazoleAntifungalDMF
73LuliconazoleAntifungalTech Pack
74NeftifineAntifungal (Topical)Tech Pack
75MethazolamideAntiglaucomaUSDMF
76CetrorelixAntigonadotropinUS DMF
77AllopurinolAntigoutDMF
78AcrivastineAntihistamineUS DMF
79Brompheniramine MaleateAntihistamineCEP
80Cetirizine Di HydrochlorideAntihistamineDMF
81Chlorpheniramine MaleateAntihistamineCEP
82Dexbrompheniramine MaleateAntihistamineDMF
83Diphenhydramine HydrochlorideAntihistamineCEP
84Mepyramine (Pyrilamine) MaleateAntihistamineCEP
85Pheniramine MaleateAntihistamineCEP
86Levocloperastine FendizoateAntihistamine - AntitussiveUnder Development
87DesloratadineAntihistamineUSDMF/ EDMF/ CEP/ TDMF/ CNDMF
88Fexofenadine HydrochlorideAntihistamineUSDMF/ EDMF/ CEP/ TDMF/ JDMF/ CNDMF
89LoratadineAntihistamineUSDMF/ CEP/ JDMF/ TDMF/ CNDMF/ EDMF/ CDMF
90DiazoxideAntihypertensiveUS DMF/CEP
91MetyrosineAntihypertensiveUSDMF
92NadololAntihypertensiveUS DMF/CEP
93NimodipineAntihypertensiveUS DMF/CEP
94Sodium NitroprussideAntihypertensiveUS DMF
95Olmesartan MedoxomilAnti-HypertensiveUSDMF/ CEP (U/Review)/ EDMF
96Erythromycin LactobionateAntiinfectiveUSDMF
97Rosuvastatin CalciumCVS -AntiLipidemicDMF
98Rosuvastatin Calcium AmorphousCVS -AntiLipidemicUSDMF / EDMF/ CEP
99Rosuvastatin Calcium CrystallineCVS -AntiLipidemicUSDMF/ CEP/ EDMF/ TDMF
100ArtemetherAntimalarialTech Pack
101Hydroxychloroquine SulphateAntimalarialDMF
102LumefantrineAntimalarialTech Pack
103Frovatriptan SuccinateAntimigraineUSDMF
104Benserazide HClAntiparkinsonCEP
105Safinamide MesylateAntiparkinsonUS DMF
106Prasugrel HCLAntiplateletTech Pack
107NitazoxanideAntiprotozoalUS DMF
108AcitretinAntipsoriaticUS DMF
109Cariprazine HClAntipsychoticUS DMF
110Chlorpromazine HClAntipsychoticUS DMF/CEP
111Paliperidone PalmitateAntipsychoticTech. Pack
112ParacetamolAntiPyreticsDMF / CEP/ USDMF
113PermethrinAntiscabiesUS DMF/CEP
114Dextromethorphan HydrobromideAntitussive - Cough SuppressantDMF
115Vonoprazan FumarateAntiulcerativeDMF
116DocosanolAntiviralUSDMF
117FavipiravirAntiviralUSDMF
118TrifluridineAntiviralUS DMF
119Arformoterol TartrateAsthma, COPDDMF
120Formoterol FumarateAsthma, COPDDMF / CEP
121Indaceterol AcetateAsthma, COPDDMF
122Indaceterol MaleateAsthma, COPDDMF
123Levo - Salbutamol HydrochlorideAsthma, COPDTech Pack
124Levo- Salbutamol SulphateAsthma, COPDDMF
125Levo- Salbutamol TartrateAsthma, COPDDMF
126Salbutamol SulphateAsthma, COPDDMF / CEP
127Salmeterol XinafoateAsthma, COPDDMF / CEP
128Tiotropium BromideAsthma, COPDDMF
129Vilanterol TrifenatateAsthma, COPDDMF
130CrisaboroleAtopic DermatitisUS DMF
131Terbutaline SulphateBronchodilatorDMF / CEP
132D-PenicillamineChelating AgentUSDMF
133PregabalinCNS - AnticonvulsantDMF / Tech Pack
134Bupropion HydrochlorideCNS - AntidepressantDMF
135Sumatriptan SuccinateCNS - AntimigraineDMF
136ClozapineCNS - AntipsychoticDMF
137QuetiapineCNS - AntipsychoticTech Pack
138Tafamidis MeglumineCNS AgentTech Pack / US DMF
139Aminocaproic AcidCoagulantUS DMF/CDMF
140Glycopyrronium BromideCOPDDMF / CEP
141Ipratropium BromideCOPDDMF / CEP
142Umeclidinium BromideCOPDDMF
143ValsartanCVS - AngiotensinDMF / US DMF/CEP
144RivaroxabanCVS - AnticoagulantUSDMF/ EDMF/ CEP (U/Review) / Tech Pack
145LamotrigineCVS - AntiepilepticDMF
146LevetiracetamCVS - AntiepilepticDMF
147MinoxidilCVS - Antihypertensive / Anti-Hair fallUnder Development
148Atorvastatin Calcium Crystalline TrihydrateCVS - Anti-LipidemicUSDMF / EDMF/ CEP/ TDMF/ KDMF/ CNDMF
149Bempedoic acidCVS - Anti-LipidemicTech Pack
150TicaglelorCVS - AntiplateletTech Pack
151Bisoprolol FumarateCVS - Beta-BlockerCEP
152NifedipineCVS - Calcium Channel BlockerTech Pack
153CiticolineCVS - Nootropic / NeuroprotectiveTech Pack
154NicorandilCVS - VasodilatorDMF
155PentoxifyllineCVS - VasodilatorCEP
156TioproninCystinuriaUS DMF
157MonobenzoneDermatological Agent (Depigmenting)Under Development
158Indocyanine GreenDiagnostic AgentUSDMF
159Isosulfan BlueDiagnostic AgentUSDMF
160Pentetic AcidDiagnostic AgentUS DMF
161RegadenosonDiagnostic AgentUS DMF
162Ethacrynate SodiumDiureticUSDMF
163Ethacrynic AcidDiureticUSDMF/CEP
164MetolazoneDiureticUSDMF/ CEP
165Elagolix SodiumEndometriosisUSDMF
166Sildenafil CitrateErectile DysfunctionUS DMF/CEP
167TadalafilErectile Dysfunction MedicationDMF
168Vardenafil HydrochlorideErectile Dysfunction MedicationDMF
169Eliglustat TartrateGaucher's DiseaseUSDMF
170FamotidineGI Track - Antacid / GERDDMF / CEP / USDMF
171Ranitidine HCL (Form-2)GI Track - Antacid / GERDUSDMF / CEP
172Esomeprazole MagnesiumGI Track - Proton Pump InhibitorTech Pack
173Omeprazole MagnesiumGI Track - Proton Pump InhibitorTech Pack
174Pantoprazole SodiumGI Track - Proton Pump InhibitorDMF / CEP / USDMF
175RabeprazoleGI Track - Proton Pump InhibitorTech Pack
176FeracrylumHemostatic Agent (Topical)Tech Pack
177NitisinoneHereditary TyrosinemiaUS DMF
178Icatibant AcetateHeriditary AngioedemaUS DMF
179MifepristoneHormone - Antiprogestin/AbortifacientTech Pack
180Estradiol HemihydrateHormone Replacement Therapy (HRT)Tech Pack
181Hydroxyprogesterone CaproateHormone Replacement Therapy (HRT)DMF
182Medroxyprogesterone acetateHormone Replacement Therapy (HRT)DMF
183Norethisterone AcetateHormone Replacement Therapy (HRT)Tech Pack
184Norethisterone baseHormone Replacement Therapy (HRT)Tech Pack
185ProgesteroneHormone Replacement Therapy (HRT)DMF
186DichlorphenamideHyperkalemic Periodic ParalysisUS DMF
187Sapropterin DiHClHyperphenylalaninemiaUS DMF
188PhytonadioneHypoprothrombinemiaUS DMF/CEP/CDMF
189Levothyroxine SodiumHypothyroidismUS DMF/CEP
190Liothyronine SodiumHypothyroidismUS DMF/CEP
191Alosetron HClIBSUS DMF
192CyclosporineImmunosuppressantDMF
193SirolimusImmunosuppressantUnder Development
194TacrolimusImmunosuppressantDMF
195RamelteonInsomniaUS DMF
196TrimetazidineMetabolic AgentTech Pack
197CladribineMultiple SclerosisUS DMF/CEP
198Cladribine-HPBCDMultiple SclerosisUS DMF
199Dimethyl FumarateMultiple SclerosisUSDMF
200ChlorzoxazoneMuscle RelaxantUS DMF
201Dantrolene SodiumMuscle RelaxantUS DMF
202Cysteamine BitartrateNephropathic CystinosisUS DMF
203Sugammadex SodiumNMJ ReversalUS DMF
204Fenoprofen CalciumNSAIDUSDMF
205IbuprofenNSAIDsDMF
206Mefenamic AcidNSAIDsEDMF
207NimesulideNSAIDsEDMF / USDMF
208Naphazoline HClOcular VasoconstrictorUS DMF/CEP
209Pimavanserin TartrateParkinson's Disease PsychosisUS DMF
210Obeticholic AcidPrimary Biliary CirrhosisUS DMF
211Pantoprazole MagnesiumProton Pump BlockerUS DMF
212PirfenidonePulmonary - AntifibroticDMF
213Fluphenazine HClSchizophreniaUSDMF
214Varenicline TartrateSmoking Cessation AidUnder Development
215FenbendazoleVeterinary - AnthelminticTech Pack
216OxfendazoleVeterinary - AnthelminticTech Pack
217Pyrantel PamoateVeterinary - AnthelminticTech Pack
218TricabendazoleVeterinary - AnthelminticTech Pack
219HalquinolVeterinary - Antifungal / AntisepticTech Pack
220Dimenazine AceturateVeterinary - AntiinfectiveTech Pack
221Hydroxocobalamin AcetateVitamin B12 SupplementDMF
222Hydroxocobalamin HydrochlorideVitamin B12 SupplementTech Pack
223Hydroxocobalamin SulphateVitamin B12 SupplementTech Pack
224MethylcobalaminVitamin B12 SupplementDMF
225Riboflavin 5 Phosphate SodiumVitamin B2 SupplementCEP
226Thiamine HClVitamin DeficiencyUS DMF