Marketing Authorisation Holder

Hetero Biopharma Limited

India

#8-3-166/1 & 2, 105 to 108, 1st Floor, G Block, East Wing, Challa Estates, Sultan Bagh, Erragadda, Hyderabad, Telangana 500114, India

Hyderabad, India

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Total Medicines

Active

Dosage Forms

Countries

Tanzania (7) Zambia (6) Rwanda (6) Botswana (6) Uganda (3) Kenya (1)

Location

#8-3-166/1 & 2, 105 to 108, 1st Floor, G Block, East Wing, Challa Estates, Sultan Bagh, Erragadda, Hyderabad, Telangana 500114, India

Open in OpenStreetMap approx.

Registration Status

Registered 28

Retained 1

Dosage Forms

Injection 5 Concentration for solution for injection/infusion 4 Vials 2 Solution for injection in single dose pre-filled syringe (PFS) for subcuteneous use or intravenous use 2 Solution for injection 2 SOLUTION FOR INJECTION 2 Lyophilized powder for injection 2 Concentrate for solution for injection 2

Local Agents / Applicants

HETERO BIOPHARMA LIMITED 16

HETERO BIOPHARMA LTD. 6

HETERO BIOPHARMA LIMITED... 6

UNISEL LTD 1

Registered Medicines

Showing 20 of 29 · Page 1 of 2

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Product	Form / Strength	Country	Reg. Number	Status
BEVAAS 100 BEVACIZUMAB	CONCETRATE FOR SOLUTION FOR INJECTION 100MG/4ML	Rwanda	Rwanda FDA-HBP-MA-005	Registered
BEVAAS 100 Bevacizumab 100/4 w/w	Solution for injection	Tanzania	TZ 19 H 0239	Registered/Compliant
BEVAAS 100 Bevacizumab 100 mg	Concentration for solution for injection/infusion 100 mg	Zambia	ZAMRA-HM-26-94	Registered/Compliant
BEVAAS 100 Polysorbate 20 1.6 mg	Vials 1.6 mg	Botswana	BOT2600005	Registered/Compliant
BEVAAS 400 BEVACIZUMAB	CONCETRATE FOR SOLUTION FOR INJECTION 400MG/16ML	Rwanda	Rwanda FDA-HBP-MA-006	Registered
BEVAAS 400 Bevacizumab 400/16 w/w	Solution for injection	Tanzania	TZ 19 H 0240	Registered/Compliant
BEVAAS 400 Bevacizumab (r-DNA origin) 400 mg	Concentration for solution for injection/infusion 400 mg	Zambia	ZAMRA-HM-26-95	Registered/Compliant
BEVAAS 400 Polysorbate 20 6.4 mg	Vials 6.4 mg	Botswana	BOT2600008	Registered/Compliant
DARBEPOETIN ALFA -	PARENTERAL ORDINARY PRE-FILLED SYRINGES 25MCG/0.42ML	Uganda	NDA/MAL/HDP/7458	Registered
DARBEPOETIN ALFA -	PARENTERAL RETARD PRE-FILLED SYRINGES 40MCG/0.4ML	Uganda	NDA/MAL/HDP/7459	Registered
DERISE 25 Darbepoetin alfa 25mcg/0.42mL	Solution for injection in single dose pre-filled syringe (PFS) for subcuteneous use or intravenous use 25mcg/0.42mL	Botswana	BOT2600009	Registered/Compliant
DERISE 25 Darbepoetin Alfa	Solution For Injection	Kenya	H2019/CTD5182/1062ER/R1	Retained
DERISE 40 Sodium Phosphate Monobasic Monohydrate 0.85 mg	Solution for injection in single dose pre-filled syringe (PFS) for subcuteneous use or intravenous use 0.85 mg	Botswana	BOT2600007	Registered/Compliant
DERISE-25 DARBEPOETIN ALFA	SOLUTION FOR INJECTION 25MCG/0.42ML	Rwanda	Rwanda FDA-HMP-MA-0063	Registered
DERISE-40 DARBEPOETIN ALFA	SOLUTION FOR INJECTION 40MCG/0.4ML	Rwanda	Rwanda FDA-HMP-MA-0064	Registered
Derise 25 Darbepoetin 25/0.42 mcg/ml	Injection 25/0.42	Tanzania	TZ 17 H 0227	Registered/Compliant
Derise 40 Darbepoetin 40 mcg/0.4ml	Injection 40	Tanzania	TZ 17 H 0226	Registered/Compliant
PAMERA Adalimumab 40 mg/0.8 ML	Injection 40	Tanzania	TAN 22 HM 0020	Registered/Compliant
RILAST 100 Polysorbate 80 7.0 mg	Concentrate for solution for injection 7.0 mg	Botswana	BOT2600004	Registered/Compliant
RILAST 100 Rituximab (r-DNA Origin) 100 mg	Concentration for solution for injection/infusion 100 mg	Zambia	ZAMRA-HM-26-286	Registered/Compliant

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29 products