madres pharma group of companies rnd pipeline products

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Tablets 20/40mg tablets (MAH : Astrazeneca, UK) 12.5mg & (Lyophilized) injecon ml 2. Toradol 30mg/ml soluon for Injecon Hydrochlorothiazide 12.5mg, tablets 80/25mg tablets. (MAH : Boehringer Ingelheim 15 Ketorolac 10mg/ml Liquid EU/UK "1. Ketorolac trometamol 10mg/ml soluon for Q2 - 2019 trometamol & 30mg/ injecon injecon(MAH : Claris Lifesciences UK limited) trometamol & 30mg/ injecon 30mg/ml injecon(MAH : Hospira Inc.,)" injecon ml 18 Gabapenn 100/300/ Hard gelan EU/UK Neuronn 100/300/400mg hard capsules Q2 - 2019 Capsules BP 400mg capsules (MAH: Pfizer Limited UK) 16 Ketorolac 15mg/ml Liquid US "Ketorolac tromethamine 15mg/ml and Q2 - 2019 17 Rosuvastan 5/10/ Film coated EU/UK Crestor 5/10/20/40mg film coated tablets Q2 - 2019 (MAH :Atnahs Pharma UK Limited)" Injecon 200mg vial injecon 20 Telmisartan and 40/ Bilayered EU/UK Micardis plus 40/12.5mg, 80/12.5mg and Q2 - 2019 Tablets 80/ Internaonal GmbH) 19 Celecoxib Capsules 100/ Hard gelan EU/UK "Celebrex capsules 100mg and 200mg` Q2 - 2019 200mg capsules (MAH :pfizer Limited,UK)" 80/25mg 21 Obecholic acid 5/10mg Film coated ROW Ocaliva 5mg and 10mg film coated tablets. Q3 - 2019 Tablets tablets (MAH:Intercept pharma limited, UK) S. No Generic Name Strength Dosage form Target Market RLD Dossier filing 1 Omega-3-acid 20000 IU 4 Dutasteride 0.5 mg Sogel EU Avodart, GlaxoSmithKline. Poland. Q3 - 2019 1gm Capsules. 2 Alfacalcidol 0.25 / 0.5 Sogel EU "ONE-ALPHA,LEO Laboratories Limited, UK." Q3 - 2019 Capsules / 1 mcg ethyl esters USP, *1 gram Sogel USA / EU LOVAZA / OMACOR Q2 - 2019 3 Colecalciferol 800 IU / Sogel EU Invita D3 / AtriumD3 / ProColCal D3 Q3 - 2019 So Capsules 1000 IU / 3200 IU / So Capsules 5 Ibuprofen 200 mg Sogel USA "Advil Liqui-Gels minis, Pfizer Catalent. USA." Q3 - 2019 Capsules (minis) Tablets 0.75mg (MAH:Medimpex UK limited)" 7 Pregabalin 75/150/ Hard gelan EU/UK "Lyrica 300 mg(MAH:Pfizer Ltd)" Q4 - 2018 Capsules 300mg capsules 8 Lidocaine Injecon 20mg/ml Liquid EU/UK N/A Q2 - 2019 6 Levonorgestrel 1.5/ Tablet EU/UK "Levonelle 1500 microgram tablet Q4 - 2018 BP 2% w/v injecon 9 Leveracetam 500/ Film coated EU/UK "Keppra 500/100mg film coated tablets Q4 - 2018 10 Clopidogrel 75mg Film coated EU/UK "Plavix tablets 75mg(MAH : Sanofi, france)" Q1 - 2019 Tabelts 1000mg tablets (MAH: UCB Pharma SA, Belgium)" Tablets tablets 11 Ibuprofen 600mg 600mg/ Liquid infusion ROW Ibuprofen 600mg Soluon for infusion Q4 - 2019 Infusion 12 Tramadol capsules 50mg Hard gelan EU/UK "Zydol 50mg capsules Q2 - 2019 Soluon for 100ml (MAH: B. Braun Melsungen AG, Germany) 13 Clarithromycin for 500mg/ Lyophilized ROW "Klaricid IV 500mg Q2 - 2019 Injecon 500mg vial injecon (MAH: Mylan products Limited, UK)" (Lyophilized) 14 Voriconazole for 200mg/ Lyophilized EU/UK/US "VFEND IV 200mg(MAH : Pfizer Limited)" Q2 - 2019 BP capsules (MAH: Grunenthal GmbH,Germany)" RND PIPELINE PRODUCTS Madres Pharma Group of Companies

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Page 1: Madres Pharma Group of Companies RND PIPELINE PRODUCTS

Tablets 20/40mg tablets (MAH : Astrazeneca, UK)

12.5mg &

(Lyophilized)

injec�on ml 2. Toradol 30mg/ml solu�on for Injec�on

Hydrochlorothiazide 12.5mg, tablets 80/25mg tablets. (MAH : Boehringer Ingelheim

15 Ketorolac 10mg/ml Liquid EU/UK "1. Ketorolac trometamol 10mg/ml solu�on for Q2 - 2019

trometamol & 30mg/ injec�on injec�on(MAH : Claris Lifesciences UK limited)

trometamol & 30mg/ injec�on 30mg/ml injec�on(MAH : Hospira Inc.,)"

injec�on ml

18 Gabapen�n 100/300/ Hard gela�n EU/UK Neuron�n 100/300/400mg hard capsules Q2 - 2019

Capsules BP 400mg capsules (MAH: Pfizer Limited UK)

16 Ketorolac 15mg/ml Liquid US "Ketorolac tromethamine 15mg/ml and Q2 - 2019

17 Rosuvasta�n 5/10/ Film coated EU/UK Crestor 5/10/20/40mg film coated tablets Q2 - 2019

(MAH :Atnahs Pharma UK Limited)"

Injec�on 200mg vial injec�on

20 Telmisartan and 40/ Bilayered EU/UK Micardis plus 40/12.5mg, 80/12.5mg and Q2 - 2019

Tablets 80/ Interna�onal GmbH)

19 Celecoxib Capsules 100/ Hard gela�n EU/UK "Celebrex capsules 100mg and 200mg` Q2 - 2019

200mg capsules (MAH :pfizer Limited,UK)"

80/25mg

21 Obe�cholic acid 5/10mg Film coated ROW Ocaliva 5mg and 10mg film coated tablets. Q3 - 2019

Tablets tablets (MAH:Intercept pharma limited, UK)

S. No Generic Name Strength Dosage form Target Market RLD Dossier filing

1 Omega-3-acid

20000 IU

4 Dutasteride 0.5 mg So�gel EU Avodart, GlaxoSmithKline. Poland. Q3 - 2019

1gm Capsules.

2 Alfacalcidol 0.25 / 0.5 So�gel EU "ONE-ALPHA,LEO Laboratories Limited, UK." Q3 - 2019

Capsules / 1 mcg

ethyl esters USP, *1 gram So�gel USA / EU LOVAZA / OMACOR Q2 - 2019

3 Colecalciferol 800 IU / So�gel EU Invita D3 / AtriumD3 / ProColCal D3 Q3 - 2019

So� Capsules 1000 IU /

3200 IU /

So� Capsules

5 Ibuprofen 200 mg So�gel USA "Advil Liqui-Gels minis, Pfizer Catalent. USA." Q3 - 2019

Capsules (minis)

Tablets 0.75mg (MAH:Medimpex UK limited)"

7 Pregabalin 75/150/ Hard gela�n EU/UK "Lyrica 300 mg(MAH:Pfizer Ltd)" Q4 - 2018

Capsules 300mg capsules

8 Lidocaine Injec�on 20mg/ml Liquid EU/UK N/A Q2 - 2019

6 Levonorgestrel 1.5/ Tablet EU/UK "Levonelle 1500 microgram tablet Q4 - 2018

BP 2% w/v injec�on

9 Leve�racetam 500/ Film coated EU/UK "Keppra 500/100mg film coated tablets Q4 - 2018

10 Clopidogrel 75mg Film coated EU/UK "Plavix tablets 75mg(MAH : Sanofi, france)" Q1 - 2019

Tabelts 1000mg tablets (MAH: UCB Pharma SA, Belgium)"

Tablets tablets

11 Ibuprofen 600mg 600mg/ Liquid infusion ROW Ibuprofen 600mg Solu�on for infusion Q4 - 2019

Infusion

12 Tramadol capsules 50mg Hard gela�n EU/UK "Zydol 50mg capsules Q2 - 2019

Solu�on for 100ml (MAH: B. Braun Melsungen AG, Germany)

13 Clarithromycin for 500mg/ Lyophilized ROW "Klaricid IV 500mg Q2 - 2019

Injec�on 500mg vial injec�on (MAH: Mylan products Limited, UK)"

(Lyophilized)

14 Voriconazole for 200mg/ Lyophilized EU/UK/US "VFEND IV 200mg(MAH : Pfizer Limited)" Q2 - 2019

BP capsules (MAH: Grunenthal GmbH,Germany)"

RND PIPELINE PRODUCTS

Madres Pharma Group of Companies

Page 2: Madres Pharma Group of Companies RND PIPELINE PRODUCTS

Madres Pharma Group of Companies

S. No Generic Name Strength Dosage form Target Market RLD Dossier filing

23 Levothyroxine 25/50/ Tablet EU/UK Eltroxin 100 mcg tablets Q3 - 2019

Prednisolone (Soluble (Amdipharm UK Limited)

27 Progesterone 100mg So� Gela�n EU/UK Utrogestan capsules 100 mg Q2 - 2019

Capsules capsules

26 Soluble 5mg Tablets EU/UK Prednesol Tablets 5mg Q3 - 2019

SG Capsule 200mg capsules (Virtus Pharmaceu�cals)

22 Dutasteride SG 0.5mg So� Gela�n EU/UK Avodart 0.5 mg so� capsules Q2 - 2019

release)

24 Progesterone 100/ So� Gela�n US Prometrium 200mg capsules Q3 - 2019

25 Dienogest Tablet 2mg Tablet UK Visanne 2 mg Tablets(Bayer Weimar GmbH) Q3 - 2019

(Immediate

Tablets 100mcg (Immediate (MAH: Mercury Pharma Group Ltd)

release)

Tablets tablets)

28 Liothyronine 20mcg Tablet EU/UK Liothyronine Tablets BP 20 mcg Q3 - 2019

Tablets BP (Immediate (MAH:Mercury Pharma Group Ltd)

release)

Tablets 684 mg (Immediate [Ibuprofen400 mg (as ibuprofen Lysine)]

29 Ibuprofen Lysine 342/ Tablets EU/UK Nurofen Express 684mg Caplets Q3 - 2019

release)

30 Tamsulosin + 0.4/ Hard gela�n UK/EU Combodart 0.5mg/0.4mg Hard capsules Q3 - 2019

Dutasteride 0.5 mg capsules (MAH: GSK UK Limited)

SG Capsule capsules (Besins Healthcare (UK) Ltd)

Capsules

33 Levothyroxine 50/ So� gela�n US Tirosint (Akrimax Pharmaceu�cals) Q3 - 2019

So� gela�n 100 mcg capsules

32 Azathioprine 50mg Tablets US Imuran Sebela Ireland Ltd Q3 - 2019

capsules

31 Sevelamer 800 mg Tablets US Renvela (Genzyme Corpora�on) Q3 - 2019

carbonate Tablets

Tablet

Sodium for Base/vial,

Sodium Tablet 0.05mg,

0.3mg

36 Chlorpromazine 25 mg/ml Injec�on US NA Q1 - 2020

0.088mg,

0.112mg,

34 Levothyroxine 0.025mg, Tablets US Synthroid Q1 - 2020

0.137mg,

0.15mg,

0.175mg,

0.1mg,

0.125mg,

Base/Vial

Injec�on USP

0.075mg,

Injec�on 100 mg

Hydrochloride

35 Micafungin 50 mg Injec�on US Mycamine Q1 - 2020

0.2mg &

RND PIPELINE PRODUCTS