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 (18) Zambia (15) 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 63

PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 18

Retained 2

3 months to expiry 1

Dosage Forms

TABLET, COATED; ORAL 16 Tablet, Film-coated 10 Film Coated Tablets 8 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 15

LAURUS LABS LIMITED - 2

DAWA LTD 2

Lupin Limited 1

LAURUS LABS Limited, 2ND... 1

Registered Medicines

Showing 20 of 84 · Page 2 of 5

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Product	Form / Strength	Country	Reg. Number	Status
DOLUTEGRAVIR SODIUM DOLUTEGRAVIR SODIUM	TABLET, COATED; ORAL 50MG	Zimbabwe	2019/7.13/5923	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
DOLUTEGRAVIR TABLETS 50MG DOLUTEGRAVIR	50 MG	Kenya	H2020/CTD7672/14855	Registered
DOLUTEGRAVIR+LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE TABLETS -	ORAL SOLID ORDINARY FILM-COATED TABLETS 50MG+300MG+300MG	Uganda	NDA/MAL/HDP/6353	Registered
DOLUTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE TABLETS 50 MG/200 MG/25 MG DOLUTEGRAVIR SODIUM, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	50 MG / 200 MG / 25 MG	Kenya	H2022/CTD9547/18539	Registered
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR ALAFENAMIDE TABLETS Dolutegravir Sodium, Lamivudine and Tenofovir Alafenamide Fumarate 50 mg/300 mg/25 mg	Film Coated Tablets 50 mg/300 mg/25 mg	Rwanda	Rwanda FDA-HMP-MA-0935	Registered
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR ALAFENAMIDE TABLETS 50 MG/300 MG/25 MG DOLUTEGRAVIR SODIUM, LAMIVUDINE AND TENOFOVIR ALAFENAMIDE FUMARATE	50 MG/300 MG/25 MG	Kenya	H2022/CTD10906/21966	Registered
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	DOLUTEGRAVIR 50MG, LAMIVUDINE 300MG AND TENOFOVIR DISOPROXIL FUMARATE 300 MG	Kenya	H2019/CTD7486/14555	Registered
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL… Dolutegravir, Lamivudine and Tenofovir Disoproxil…	Film-Coated Tablet	Kenya	H2019/CTD7486/14555/R1	Retained
DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE Dolutegravir sodium 50 mg, Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg	Film coated tablets 50mg/300mg/300mg	Rwanda	Rwanda FDA-HMP-MA-0937	Registered
DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFANAMIDE	TABLET, COATED; ORAL 50; 200; 25MG	Zimbabwe	2023/7.13/6493	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET; ORAL 50; 300; 300MG	Zimbabwe	2019/7.13/5803	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
Darunavir Darunavir 800 mg	Tablet, Film-coated 800	Tanzania	TZ 19 H 0225	Registered/Compliant
DARUNAVIR Darunavir 400 mg	Film Coated Tablet 400	Tanzania	TZ 19 H 0224	Registered/Compliant
Darunavir Darunavir 600 mg	Film Coated Tablet 600	Tanzania	TZ 19 H 0223	Registered/Compliant
Darunavir 400mg Tablets Darunavir 400mg mg	Film Coated Tablets 400mg mg	Zambia	469/003	Registered/Compliant
Darunavir 600mg Tablets Darunavir 600mg mg	Tablets+ Filmcoated 600mg mg	Zambia	469/004	Registered/Compliant
Darunavir 800mg Tablets Darunavir Ethanolate 800 mg	Tablets+ Filmcoated 800 mg	Zambia	469/005	Registered/Compliant
Darunavir tablets 400 mg Darunavir 400 mg	Film Coated Tablet 400	Tanzania	TZ 19 H 0224	Registered/Compliant
DARUNAVIR TABLETS 800 MG Darunavir 800 mg	Tablet, Film-coated 800	Tanzania	TZ 19 H 0225	Registered/Compliant
Dolutegravir 50mg + Lamivudine 300mg + Tenofovir 300mg Dolutegravir Sodium 50 mg,Lamivudine 300 mg,Tenofovir Disoproxil Fumarate 300 mg	Tablet Uncoated 300 mg,50 mg	Zambia	469/001	Registered/Compliant

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84 products