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Marketing Authorisation Holder

MYLAN LABORATORIES LIMITED

INDIA

GMP Certified

Prestige Tech Park,Platina-3, PRESTIGE TECH PARK, 7th to 12th, Kadubeesanahalli, Bengaluru, Bellandur Amanikere, Karnataka 560103, India

Bengaluru, India

Maps

411

Total Medicines

293

Active

8

Dosage Forms

8

Countries

Tanzania (87) Zimbabwe (84) Botswana (56) Kenya (44) Uganda (43) Zambia (41) Ghana (30) Rwanda (26)

Location

Prestige Tech Park,Platina-3, PRESTIGE TECH PARK, 7th to 12th, Kadubeesanahalli, Bengaluru, Bellandur Amanikere, Karnataka 560103, India

Registration Status

Registered 293
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 67
Valid 17
PRESCRIPTION PREPARATIONS 10TH SCHEDULE, (P.P.10) 15
3 months to expiry 13
Unknown 3
PHARMACIST INITIATED MEDICINES, (P.I.M.) 2
Retained 1

Therapeutic Classes

GENERIC/BIOSIMILARS 33
NEW/INNOVATOR 7

Local Agents / Applicants

MYLAN LABORATORIES LIMITED 149
Mylan Laboratories Limited 124
MYLAN LABORATORIES LIMITED... 55
MYLAN LABORATORIES LIMITED [OTL] 15
Worldwide Healthcare... 13
Worldwide Healthcare... 9

Registered Medicines

Showing 20 of 411 · Page 5 of 21

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Product Country Status

CLAVICIN [AMOXICILLIN AND POTASSIUM CLAVULANATE FOR INJECTION 1.2G)

AMOXICILLIN SODIUM AND CLAVULANATE POTASSIUM EQUIVALENT TO AMOXICILLIN 1000 MG AND CLAVULANIC ACID 200MG.

Kenya Registered

CONTRASAFE

Medroxyprogesterone acetate USP 150mg/ml

Rwanda Registered

CYCLOSERINE

-

Uganda Registered

CYCLOSERINE CAPSULES USP 250 MG

CYCLOSERINE USP

Kenya Registered

Cabazitaxel 60 Injection

Cabazitaxel 40 mg/ml

Zambia Registered/Compliant

Contrasafe 150 Suspension for Injection

Medroxyprogesterone Acetate BP/Ph. Eur 150 mg

Zambia Registered/Compliant

DACLATASVIR + SOFOSBUVIR

-

Uganda Registered

DARUNAVIR

-

Uganda Registered

DARUNAVIR

-

Uganda Registered

DARUNAVIR & RITONAVIR

darunavir, ritonavir

Botswana Registered/Compliant

DARUNAVIR/RITONAVIR TABLETS 400 MG/50 MG

DARUNAVIR ETHANOLATE EQUIVALENT TO DARUNAVIR 400 MG AND RITONAVIR 50 MG

Kenya Registered

DARUNAVIR; RITONAVIR

DARUNAVIR; RITONAVIR

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

DAXIMRA 110

Dabigatran Etexilate Mesylate equivalent to Dabigatran Etexilate 110 mg,Empty hard hypromellose capsule, size ‘1’ 01 No Nos,Hydroxyl Propyl Methyl Cellulose 3.271 mg/6 mL,Hydroxypropyl Cellulose . 25.373 mg/6 mL,Isoproply Alcolhol q.s q.s,Isopropyl Alcohol q.s q.s,Talc 1.467 mg/6 mL,Talc 19.066 mg/6 mL,Talc 5.126 mg/6 mL,Tartaric Acid Pellets 129.800 mg/6 mL,methylene chloride q.s q.s

Tanzania Registered/Compliant

DAXIMRA 150

Dabigatran Etexilate Mesylate equivalent to Dabigatran Etexilate 150 mg/6 mL,Empty hard hypromellose capsule, size ‘0’ 01 No. Nos,Hydroxyl Propyl Methyl Cellulose 4.460 mg/6 mL,Hydroxypropyl Cellulose . 34.600 mg/6 mL,Isopropyl Alcohol q.s q.s,Talc 2.000 mg/6 mL,Talc 26.000 mg/6 mL,Talc 6.990 mg/6 mL,Tartaric Acid Pellets 177.000 mg/6 mL,methylene chloride q.s q.s

Tanzania Registered/Compliant

DAXIMRA 150

DABIGATRAN ETEXILATE

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

DAXIMRA 75

Dabigatran Etexilate Mesylate equivalent to Dabigatran Etexilate 75 mg,Empty hard hypromellose capsule, size ‘2’ 01 No Nos,Hydroxyl Propyl Methyl Cellulose 2.230 mg/6 mL,Hydroxypropyl Cellulose . 17.300 mg/6 mL,Isopropyl Alcohol q.s q.s,Talc 1.000 mg/6 mL,Talc 13.000 mg/6 mL,Talc 3.495 mg/6 mL,Tartaric Acid Pellets 88.500 mg/6 mL,methylene chloride q.s q.s

Tanzania Registered/Compliant

DELAMANID

-

Uganda Registered

DEMTIBI

Delamanid SD Powder 50 mg/6 mL,Ethanol, Anhydrous q.s q.s,Hypromellose phthalate (HP-50) 150.00 mg/6 mL,Povidone (K-25) 25.00 mg/6 mL,all-rac-α-Tocopherol 4.00 mg/6 mL,methylene chloride q.s q.s

Tanzania Registered/Compliant

DEMTIBI

Delamanid Tablets 50 mg

Zambia Registered/Compliant

DEMTIBI

Delamanid 50mg

Botswana Registered/Compliant