Marketing Authorisation Holder

Laurus Labs Limited

INDIA

2nd Floor, Serene Chambers,, Road Number 5,, SBI Executive Enclave, Banjara Hills, Green Valley, Banjara Hills, Hyderabad, Telangana 500034, India

Hyderabad, India

Maps

Total Medicines

Active

Dosage Forms

Countries

Tanzania (21) Zimbabwe (17) Zambia (14) Kenya (14) Rwanda (12) Uganda (3) Ghana (1)

Location

2nd Floor, Serene Chambers,, Road Number 5,, SBI Executive Enclave, Banjara Hills, Green Valley, Banjara Hills, Hyderabad, Telangana 500034, India

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Registration Status

Registered 62

PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 17

Retained 2

3 months to expiry 1

Dosage Forms

TABLET, COATED; ORAL 15 Tablet, Film-coated 10 Film Coated Tablets 7 Film Coated Tablet 7 Tablets+ Filmcoated 5 Film-coated Tablets 4 Film coated tablets 4 ORAL SOLID ORDINARY FILM-COATED TABLETS 3

Therapeutic Classes

GENERIC/BIOSIMILARS 12

Local Agents / Applicants

LAURUS LABS LIMITED 58

Laurus Labs Limited 14

LAURUS LABS LIMITED - 2

DAWA LTD 2

Lupin Limited 1

LAURUS LABS Limited, 2ND... 1

Registered Medicines

Showing 20 of 82 · Page 3 of 5

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Product	Form / Strength	Country	Reg. Number	Status
Dolutegravir Sodium 50mg Tablets Dolutegravir Sodium 50 mg	Film-coated Tablets 50 mg	Zambia	469/002	Registered/Compliant
Dolutegravir Tablets 50 mg Dolutegravir Sodium 50 mg	Tablet, Film-coated	Tanzania	TZ 19 H 0228	Registered/Compliant
Dolutegravir+Lamivudine+Tenofovir Disoproxil Fumarate Dolutegravir Sodium equivalent to Dolutegravir 50 mg,Lamivudine 300 mg,Tenofovir Disoproxil Fumarate 300 mg	Tablets 50/300/300	Tanzania	TZ 19 H 0034	Registered/Compliant
Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets 50mg/200mg/25mg Dolutegravir Sodium 50 mg,Emtricitabine 200 mg,Tenofovir Alafenamide Fumarate 25 mg	Film-coated Tablets 200 mg,25 mg,50 mg	Zambia	ZAMRA-HM-24-37	Registered/Compliant
Dolutegravir,Emtrictabine and Tenofovir Alafenamide Croscarmellose Sodium(AC-DI-SOL) 28.000 mg/6 mL,Dolutegravir Sodium 50 mg/6 mL,Emtricitabine 200 mg/6 mL,Magnesium stearate (Ligamed MF-2-V) 5.630 mg/6 mL,Mannitol (Pearlitol 50 C) 137.280 mg/6 mL,Microcrystalline cellulose (Pharmacel 102) 88.695 mg/6 mL,Microcrystalline cellulose (pharmacel 101) 60.000 mg/6 mL,Opadry II white 85F580019 19.500 mg/6 mL,Povidone (Kollidon K 30) 15.000 mg/6 mL,Purified Water q.s q.s,Sodium Starch glycolate (Type A) (Primojel) 22.500 mg/6 mL,Sodium Starch glycolate (Type A) (Primojel) 9.600 mg/6 mL,Tenofovir Alafenamide 25 mg/6 mL,magnessium stearate 2.630 mg/6 mL	Film Coated Tablet	Tanzania	TAN 23 HM 0019	Registered/Compliant
Dolutegravir,Lamivudine and Tenofovir Alafenamide Tablets 50 mg/300 mg/25 mg Croscarmellose Sodium(AC-DI-SOL) 22.00 mg/6 mL,Dolutegravir Sodium 50 mg/6 mL,Lactose Monohydrate (Flowlac 100) 94.95 mg/6 mL,Lamivudine 300 mg,Magnesium Sterate (Ligamed MF-2-V) 11.00 mg/6 mL,Mannitol (Pearlitol 50 C) 132.38 mg/6 mL,Microcrystalline Cellulose (PH102) 184.00 mg/6 mL,Microcrystalline cellulose PH 101 60.00 mg/6 mL,Opadry II white 85F580019 27.60 mg/6 mL,Povidone, (kollidon 30) 20.00 mg/6 mL,Purified Water Q.s mg,Purified Water Q.s mg/6 mL,Sodium Starch Glycolate Type A (Primojel) 15.00 mg/6 mL,Tenofovir Alafenamide Fumarate 25 mg/6 mL	Film Coated Tablet	Tanzania	TAN 23 HM 0183	Registered/Compliant
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE Efavirenz 600 mg, Lamivudine 300 mg, and Tenofovir Disoproxil Fumarate 600 mg	Film coated tablets 600 mg, 300 mg, 600 mg	Rwanda	Rwanda FDA-HMP-MA-1173	Registered
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS (400 MG/300 MG/300 MG) EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ USP 400 MG, LAMIVUDINE USP 300 MG AND TENOFOVIR DISOPROXIL FUMARATE 300 MG EQUIVALENT TO 245 MG OF TENOFOVIR DISOPROXIL.	Kenya	H2020/CTD7950/16359	Registered
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS (600 MG/300 MG/300 MG) EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ 600MG, LAMIVUDINE 300MG AND TENOFOVIR DISOPROXIL FUMARATE 300MG EQUIVALENT TO 245 MG OF TENOFOVIR DISOPROXIL.	Kenya	H2020/CTD7947/15421	Registered
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 400 MG/ 300 MG/ 300 MG Efavirenz 400 mg,Lamivudine 300 mg,Tenofovir Disoproxil Fumarate 300 mg	Tablets	Tanzania	TAN 20 HM 0100	Registered/Compliant
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET, COATED; ORAL 600; 300; 300MG	Zimbabwe	2021/7.13/6093	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET, COATED; ORAL 400; 300; 300M	Zimbabwe	2021/7.13/6210	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
EMTRICITABINE -	ORAL SOLID ORDINARY FILM-COATED TABLETS 200 MG	Uganda	NDA/MAL/HDP/11139	Registered
EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE	TABLET 200/300MG	Rwanda	Rwanda FDA-HMP-MA-1858	Registered
EMTRICITABINE ; TENOFOVIR ALAFENAMIDE EMTRICITABINE; TENOFOVIR ALAFENAMIDE	TABLET, COATED; ORAL 200; 25MG	Zimbabwe	2023/7.13/6485	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 200 MG/ 300 MG EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE 200 MG AND TENOFOVIR DISOPROXIL FUMARATE 300MG	Kenya	H2020/CTD7616/14828	Registered
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET, COATED; ORAL 200; 300MG	Zimbabwe	2021/7.13/6104	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
Efavirenz 600mg + Lamivudine 300mg + Tenofovir 300mg Tablets Efavirenz 600 mg,Lamivudine 300 mg,Tenofovir Disoproxil Fumarate 300 mg	Film Coated Tablets 300 mg,600 mg	Zambia	469/008	Registered/Compliant
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets 600 mg/ 300 mg/ 300 mg Efavirenz 600 mg,Lamivudine 300 mg,Tenofovir Disoproxil Fumarate 300 mg	Tablet, Film-coated	Tanzania	TAN 20 HM 0120	Registered/Compliant
Emtricitabine 200mg + Tenofovir Disoproxil Fumarate 300mg Tablets EMTRICITABINE 200mg TENOFOVIR 300mg 200mg + 300mg mg	Tablets+ Filmcoated 200mg + 300mg mg	Zambia	469/009	Registered/Compliant

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