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Marketing Authorisation Holder

Mylan Laboratories

India

GMP Certified

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

Bengaluru, India

Maps

376

Total Medicines

265

Active

8

Dosage Forms

7

Countries

Botswana (98) Tanzania (76) Zimbabwe (71) Zambia (40) Ghana (37) Kenya (28) Rwanda (26)

Location

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

Registration Status

Registered 265
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 56
Valid 24
3 months to expiry 13
PRESCRIPTION PREPARATIONS 10TH SCHEDULE, (P.P.10) 12
Unknown 3
PHARMACIST INITIATED MEDICINES, (P.I.M.) 3

Therapeutic Classes

NEW/INNOVATOR 1

Local Agents / Applicants

Mylan Laboratories Limited 102
MYLAN LABORATORIES LIMITED... 90
MYLAN LABORATORIES LIMITED 49
MYLAN LABORATORIES LIMITED [OTL] 18
Worldwide Healthcare... 13
Worldwide Healthcare... 9

Registered Medicines

Showing 20 of 376 · Page 4 of 19

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Product Country Status

CASPOFUNGIN 50 MYLAN

Caspofungin Acetate 60.600 mg

Zambia Registered/Compliant

CASPOFUNGIN 70 MYLAN

Caspofungin Acetate 60.600 mg

Zambia Registered/Compliant

CASPOFUNGIN MYLAN

CASPOFUNGIN

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

CASPOFUNGIN MYLAN

CASPOFUNGIN

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

CELEBREX

CELECOXIB

Kenya Registered

CONTRASAFE

Medroxyprogesterone acetate USP 150mg/ml

Rwanda Registered

Cabazitaxel 60 Injection

Cabazitaxel 40 mg/ml

Zambia Registered/Compliant

DARUNAVIR & RITONAVIR

darunavir, ritonavir

Botswana Registered/Compliant

DARUNAVIR+RITONAVIR TABLETS

DARUNAVIR+RITONAVIR

Ghana Valid

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 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

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

DEMTIBI

DELAMANID

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

DEMTIBI TABLETS

DELAMANID

Ghana Valid

DIPTATRIS 10/160/12.5MG

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Zimbabwe PRESCRIPTION PREPARATIONS 10TH SCHEDULE, (P.P.10)

DIPTATRIS 10/160/25MG

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Zimbabwe PRESCRIPTION PREPARATIONS 10TH SCHEDULE, (P.P.10)