Product List - CTD Dossier 29.08.

23
Sr. Generic Name/Dosage Form/Strength Therapeutic segment Shelf Life Packing BE report BE Location Innovator Sample MOQ Remark Dossiers
No. availability details Timelines

1 Entecavir Tablets 0.5 mg Anti-Retroviral, 36 months √ India - Vergo - US/EU Baraclude 0.5 mg 100,000 ROW market Ready
Hepatitis B approved Bristol Myers Squibb, Tablets
3x10 Alu-Alu Blister Germany

2 Febuxostat Tablets 40 mg Anti - Gout 36 months 3 x 10 Alu-Alu Blister √ India - Vergo - US/EU Biowaiver 100,000 ROW & Semiregulated Ready
3x10 Alu-PVC approved Tablets
Blister 30's
bottle pack
3 Febuxostat Tablets 80 mg Anti - Gout 36 months 3 x 10 Alu-Alu Blister √ India - Vergo - US/EU Adenuric, Germany 100,000 ROW & Semiregulated Ready
3x10 Alu-PVC approved Tablets
Blister 30's
bottle pack
4 Paracetamol Tablets 500 mg ( Film Anti-Pyretic 36 months 10 x 10 Alu-PVC Blister Not available Not available CDP with Panado, 100,000 ROW & Semiregulated Ready
Coated) Adcock, South Africa & Tablets
Calpol, GSK

5 Deferiprone Capsules 500 mg Iron- Chelator 36 months Not available Not available CDP With 100,000 ROW & Semiregulated Ready
Ferriprox,Apotex, Tablets
3x10 Alu-Alu Blister Europe

6 Esomeprazole Magnesium Delayed Proton Pump Inhibitor 36 months 2 x 7 Alu-Alu Blister √ Vietnam - Local Nexium 100,000 ROW market Ready
Release Capsules USP 40 mg approval Astrazeneca Tablets
pharmaceuticals

7 Moxifloxacin Tablets USP 400 mg Anti Bacterial 24 months 1x10 Alu-Alu Blister Not available Not available -- 100,000 ROW market Ready
Tablets
8 Omeprazole Capsules 20 mg Proton Pump Inhibitor 24 months Not available Not available -- 100,000 ROW market Ready
3x10 Alu-Alu Blister Tablets
6x10 Alu-Alu Blister
10x10 Alu-Alu Blister,
14's & 30's HDPE
9 Tenofovir Alafenamide Tablets 25 mg Anti-Retroviral, HIV, 36 months 30's Bottle √ Vietnam - Local Vemlidy, Gilead 100,000 ROW & Semiregulated Ready
Hepatitis B approval Tablets
10 Tenofovir Disoproxil Fumarate 300 mg, Anti-Retroviral, HIV, 36 months 30's Bottle Not available Not available __ 100,000 ROW Ready
Lamivudine 300 mg and Efavirenz 600 mg Hepatitis B Tablets
Tablets

11 Tenofovir Disoproxil Fumarate 300 mg + Anti-Retroviral, HIV, 24 months 30's Bottle Not available Not available __ 100,000 ROW Ready
Lamivudine 100 mg Tablets Hepatitis B Tablets
12 Tenofovir Disoproxil Fumarate Tablets 300 Anti-Retroviral, HIV, 36 months 3x10 Alu-Alu Blister √ Vietnam - Local Viread 100,000 ROW & Semiregulated Ready
mg Hepatitis B 30's Bottle approval Gilead Lifesciences, USA Tablets Market
BE to be conducted
for Semi regulated

13 Tenofovir 300 + Emtricitabine 200 mg Anti-Retroviral, HIV, 36 months 30's Bottle Not available CDP with Truveda, 100,000 Ready
Hepatitis B Gilead Tablets
14 Rivaroxaban Tablets 10 mg Anti-Coagulant 24 months 3x10 Alu-Alu Blister √ Raptim Research Xarelto, Bayer 100,000 Regulated/ Ready
30's Bottle EU/US Approved Tablets Semiregulated/ROW
facility

15 Rivaroxaban Tablets 15 mg Anti-Coagulant 24 months 3x10 Alu-Alu Blister Biowaiver Raptim Research Xarelto, Bayer 100,000 Regulated/ Ready
30's Bottle EU/US Approved Tablets Semiregulated/ROW
facility

16 Rivaroxaban Tablets 20 mg Anti-Coagulant 24 months 3x10 Alu-Alu Blister √ Raptim Research Xarelto, Bayer 100,000 Regulated/ Ready
30's Bottle EU/US Approved Tablets Semiregulated/ROW
facility

17 Paracetamol Tablets 650 mg ( Uncoated) Anti- Pyretic 36 months 10x15 Alu-Alu Blister Biowaiver CDP with Calpol 650 100,000 ROW & Semiregulated Ready
Tablets
18 Paracetamol Tablets 500 mg ( Uncoated) Anti- Pyretic 36 months 10x10 Alu-Alu Blister Biowaiver CDP with Panado, 100,000 ROW & Semiregulated Ready
Adcock, South Africa & Tablets
Calpol, GSK

19 Ciprofibrate Tablets 100 mg Anti - Lipidemic 24 months 3x10 Alu-Alu Blister Not available Not available --- 100,000 ROW market Ready
Tablets
20 Hydroxychloroquine Sulphate Tablets BP Anti- Malarial 24 months 3x10 blister Not available Not available --- 100,000 ROW market Ready
200 mg Tablets
21 Triclabendazole Anthelmintics - Anti- 24 months 1x4 Alu-PVC/PVDC Not available Not available --- 100,000 ROW market Ready
Worms, Fascioliasis and Blister Tablets
paragonimiasis

22 Sitagliptin USP Tablets 50 mg Anti- Diabetic 24 months 3x10 Alu-Alu Blister Biowaiver Vietnam - Local CDP with Januvia, Merck 100,000 ROW & Semiregulated Ready
approval Tablets
23 Sitagliptin USP Tablets 100 mg Anti- Diabetic 24 months 3x10 Alu-Alu Blister √ Vietnam - Local CDP with Januvia, Merck 100,000 ROW & Semiregulated Ready
approval Tablets
24 Rifaximin Tablets 200 mg Antibiotic, Traveler's 24 months 3x10 Alu-Alu Blister Not Available --- 100,000 ROW Ready
Diarrhea Tablets
25 Rifaximin Tablets 550 Antibiotic, Hepatic 36 months 3x10 Alu-Alu Blister Not Available --- 100,000 ROW Ready
Encephalopathy Tablets
26 Azithromycin Tablets USP 250 mg Anti - Biotics 24 months 1x6s Alu Pvc Not available Not available CDP with Zithromax, Pfize 100,000 ROW market Ready
Tablets
27 Azithromycin Tablets USP 500 mg Anti - Biotics 24 months 1x5s Alu-Pvc Not available Not available CDP with Zithromax, Pfize 100,000 ROW market Ready
Tablets
28 Apixaban Tablets 2.5 mg Anti-Coagulant 24 months 3x10 Alu-Alu Blister Raptim Research Biowaiver 100,000 Regulated/ Ready
30's Bottle EU/US Approved Tablets Semiregulated/ROW
facility
Biowaiver
29 Apixaban Tablets 5.0 mg Anti-Coagulant 24 months 3x10 Alu-Alu Blister Available Raptim Research Eliquis, BMS 100,000 Regulated/ Ready
30's Bottle EU/US Approved Tablets Semiregulated/ROW
facility
30 Entecavir Tablets 0.5 mg For EU Anti-Retroviral, 24 months 3x10 Alu-Alu Blister Biowaiver ___ Baraclude 0.5 mg 100,000 WHO PQ / Regulated/
Hepatitis B Bristol Myers Squibb, Tablets Semiregulated / ROW
Germany
Sep-23
31 Entecavir Tablets 1.0 mg For EU Anti-Retroviral, 24 months 3x10 Alu-Alu Blister Aug-23 Raptim Research Baraclude 1 mg 100,000 WHO PQ / Regulated/
Hepatitis B EU/US Approved Bristol Myers Squibb, Tablets Semiregulated / ROW
facility Germany
Oct-23
32 Ticagrelor Tablets 60 mg Anti-Platelet 24 months 3x10 Alu-Alu Blister Biowaiver ___ Brilique 60 mg 100,000 Regulated/
30's Bottle Tablets Semiregulated/ROW
Jan-24
33 Ticagrelor Tablets 90 mg Anti-Platelet 24 months 3x10 Alu-Alu Blister Jul-23 Raptim Research Brilique 90 mg 100,000 Regulated/
30's Bottle EU/US Approved Tablets Semiregulated/ROW
facility
Jan-24
34 Rivaroxaban Tablets 2.5 mg Anti-Coagulant 24 months 3x10 Alu-Alu Blister Biowaiver ___ Xarelto, Bayer 100,000 Regulated/
30's Bottle Tablets Semiregulated/ROW
Oct-23
35 Sitagliptin With Metformin Tablets 50 mg/ Anti- Diabetic 24 months 3x10 Alu-Alu Blister BE requirement 100,000 Regulated/ Sep-23
500 mg IR 30's Bottle - TBC Tablets Semiregulated/ROW
36 Sitagliptin With Metformin Tablets 50 mg/ Anti- Diabetic 24 months 3x10 Alu-Alu Blister Aug-23 Raptim Research Janumet, Merck 100,000 Regulated/ Sep-23
850 mg IR 30's Bottle EU/US Approved Tablets Semiregulated/ROW
facility

37 Sitagliptin With Metformin Tablets 50 mg/ Anti- Diabetic 24 months 3x10 Alu-Alu Blister Aug-23 Raptim Research Janumet, Merck 100,000 Regulated/ Sep-23
1000 mg IR 30's Bottle EU/US Approved Tablets Semiregulated/ROW
facility

38 Dolutegravir 50 mg Tablet Anti-Retroviral 24 months 3x10 Alu-Alu Blister Sep-23 AnaCihar Tivicay 50 mg, Viv Health 100,000 WHO PQ/ Regulated Dec-23
30's Bottle Tablets
39 Linagliptin 5 mg Tablet Anti- Diabetic 24 months 3x10 Alu-Alu Blister Oct-23 Trajenta,Boehringer Ingel 100,000 Regulated/ Mar-24
30's Bottle Tablets Semiregulated/ROW
40 Prolonged Release Metformin Tablets 500 Anti- Diabetic 24 months 3x10 Alu-Alu Blister √ India - Vergo - US/EU Glucophage SR 500, 100,000 Regulated/ Apr-24
mg approved Merck Tablets Semiregulated/ROW
41 Prolonged Release Metformin Tablets 750 Anti- Diabetic 24 months 3x10 Alu-Alu Blister √ India - Vergo - US/EU Glucophage SR 750, 100,000 Regulated/ Apr-24
mg approved Merck Tablets Semiregulated/ROW
42 Prolonged Release Metformin Tablets Anti- Diabetic 24 months 3x10 Alu-Alu Blister √ India - Vergo - US/EU Glucophage SR 1000, 100,000 Regulated/ Apr-24
1000 mg approved Merck Tablets Semiregulated/ROW
 Products Under Development at R&D facility
Generic Name/Dosage Form/Strength
BE to be Tentative timeline
Sr. No. Non-ART Therapeutic segment Market
conducted of Dossier
1 Rifaximin Tablets 200 mg Antibiotic, Traveler's Regulated/Semiregulated/ROW Yes Q4 FY 23-24
2 Rifaximin Tablets 550 mg Diarrhea Hepatic
Antibiotic, Regulated/Semiregulated/ROW Yes Q1 FY 24-25
Encephalopathy
3 Linagliptin 2.5 mg + Meformin 500 mg IR Anti- Diabetic Regulated/Semiregulated/ROW Yes Q4 FY 24-25
4 Linagliptin 2.5 mg + Meformin 850 mg IR Anti- Diabetic Regulated/Semiregulated/ROW Yes Q4 FY 24-25
5 Linagliptin 2.5 mg + Meformin 1000 mg IR Anti- Diabetic Regulated/Semiregulated/ROW Yes Q4 FY 24-25
6 Empagliflozin 10 mg IR Anti- Diabetic Regulated/Semiregulated/ROW Yes To be confirm
7 Empagliflozin 25 mg IR Anti- Diabetic Regulated/Semiregulated/ROW Yes To be confirm
8 Empagliflozin 5 mg + Metformin 850 mg IR Tablet Anti- Diabetic Regulated/Semiregulated/ROW Yes To be confirm
9 Empagliflozin 5 mg + Metformin 1000 mg IR Anti- Diabetic Regulated/Semiregulated/ROW Yes To be confirm
10 Empagliflozin 12.5 mg + Metformin 850 mg IR Anti- Diabetic Regulated/Semiregulated/ROW Yes To be confirm
11 Empagliflozin 12.5 mg + Metformin 1000 mg IR Anti- Diabetic Regulated/Semiregulated/ROW Yes To be confirm
12 Empagliflozin 10 mg + Linagliptin 5 mg IR Anti- Diabetic Regulated/Semiregulated/ROW Yes To be confirm
13 Empagliflozin 25 mg + Linagliptin 5 mg IR Anti- Diabetic Regulated/Semiregulated/ROW Yes To be confirm
14 Sofosbuvir Tablets 400 mg Anti-Viral Regulated/Semiregulated/ROW No To be confirm
15 Obeticholic Acid Tablets 10 mg Hepatic Disorders Regulated/Semiregulated/ROW No To be confirm
16 Obeticholic Acid Tablets 5 mg Hepatic Disorders Regulated/Semiregulated/ROW No To be confirm
17 Cariprazine Capsules To treat bipolar disorder and Regulated/Semiregulated/ROW Yes Q1 FY 25-26
schizophrenia
18 Vortioxetine Tablets 5/10/15/20 Anti depressant Regulated/Semiregulated/ROW Yes Q1 FY 25-26
19 Apremilast Tablets 10/20/30 mg Psoriatic Arthritis Regulated/Semiregulated/ROW Yes Q3 FY 24-25
20 Calcium Alpha Ketoglutarate + Vitamin A + Vitamin Renal supplement Regulated/Semiregulated/ROW No Q1 FY 24-25
D3 and Calcium Tablets