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Marketing Authorisation Holder

BHARAT BIOTECH INTERNATIONAL LIMITED

India

BBIL, Genome Valley Rd, Shamirpet, Turkapally, Hyderabad, Telangana 500101, India

Hyderabad, India

Maps

29

Total Medicines

23

Active

8

Dosage Forms

6

Countries

Tanzania (8) Botswana (6) Zimbabwe (5) Zambia (5) Kenya (4) Ghana (1)

Location

BBIL, Genome Valley Rd, Shamirpet, Turkapally, Hyderabad, Telangana 500101, India

Registration Status

Registered 23
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 5
Valid 1

Therapeutic Classes

NEW/INNOVATOR 2
GENERIC/BIOSIMILARS 2

Local Agents / Applicants

BHARAT BIOTECH... 15
Bharat Biotech... 6
BHARAT BIOTECH... 6
PRISMA PHARMA FZE 1
PHILLIPS PHARMACEUTICALS... 1

Distributing Wholesalers

Licensed wholesalers / distributors that carry this MAH's brands.

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Registered Medicines

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Product Country Status

COVAXIN

WHOLE VIRION, INACTIVATED CORONA VIRUS BULK

Kenya Registered

FLORA NORM POWDER (Each sachet contains Saccharomyces boulardii 250mg)

Saccharomyces boulardii

Ghana Valid

Flora Norm

Saccharomyces Boulardii 250 mg

Tanzania Registered/Compliant

Indirab Rabies Vaccine BP + Diluent for Indirab Injection

Human Albumin 1 IU/ml,Maltose 1 IU/ml,Thiomersal 0.01 %

Zambia Registered/Compliant

REVAC-B

HEPATITIS B SURFACE ANTIGEN

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

ROTAVAC

Dipotassium hydrogen orthophosphate 0.625 mg/0.5ml,Dulbecco’s Modified Eagle’s Medium (DMEM) 4.4 mg/0.5ml,Kanamycin Acid Sulphate equivalent to Kanamycin 15 mcg/0.5ml,Neomycin Sulphate 15 mcg/0.5ml,Potassium Dihydrogen Orthophosphate 0.258 mg/0.5ml,Potassium L-glutamate monohydrate 1.0 mg/0.5ml,Rotavirus 116E Live bulk NLT 10^5.00 FFU per 0.5 mL,Sucrose BP 39.00 mg/0.5ml,Water for Injection q.s ml/dose

Tanzania Registered/Compliant

ROTAVAC

Dipotassium hydrogen orthophosphate 0.625 mg/0.5ml,Dulbecco’s Modified Eagle’s Medium (DMEM) 4.4 mg/0.5ml,Kanamycin Acid Sulphate equivalent to Kanamycin 15 mcg/0.5ml,Neomycin Sulphate 15 mcg/0.5ml,Potassium Dihydrogen Orthophosphate 0.258 mg/0.5ml,Potassium L-glutamate monohydrate 1.0 mg/0.5ml,Rotavirus 116E Live bulk NLT 10^5.00 FFU per 0.5 mL,Sucrose BP 39.00 mg/0.5ml,Water for Injection q.s. ml/dose

Tanzania Registered/Compliant

ROTAVAC

ROTAVIRUS, STRAIN 116E

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

ROTAVAC 5D

ROTAVIRUS 116E BULK

Kenya Registered

ROTAVAC 5D®

Rotavirus Vaccine BP NLT 10^5.0 FFU

Botswana Registered/Compliant

ROTAVAC 5D®

Rotavirus Vaccine BP NLT 10^5.0 FFU

Botswana Registered/Compliant

ROTAVAC 5D®

Rotavirus Vaccine BP NLT 10^5.0 FFU

Botswana Registered/Compliant

ROTAVAC VACCINE(LIVE ATTENUATED ORAL)

ROTAVIRUS 116E BULK

Kenya Registered

Revac-B

Hepatitis B Vaccine 10 mcg

Tanzania Registered/Compliant

Revac-B

Aluminium Hydroxide gel equivalent to Al+++ 0.50 mg/6 mL,Hepatitis B Surface antigen >20 mcg,Phosphate Buffer saline q.s. to 1.0mL q.s to 1mL,Purified Aqueous HBsAg Bulk ≥20 microgram,Thiomersal 0.05 mg/6 mL

Tanzania Registered/Compliant

Revac-B

Aluminium Hydroxide gel equivalent to Al+++ 0.25 mg/6 mL,Hepatitis B Surface antigen >10 micrograms,Phosphate Buffer saline q.s. to 0.5 ml N/A,Thiomersal (as preservative) 0.025 mg/6 mL

Tanzania Registered/Compliant

Revac-B

Aluminium Hydroxide gel equivalent to Al+++ 0.50 mg/6 mL,Hepatitis B Surface antigen >20 mcg,Phosphate Buffer saline q.s. to 1.0mL q.s,Purified Aqueous HBsAg Bulk ≥20 microgram,Thiomersal 0.05 mg/6 mL

Tanzania Registered/Compliant

Rotavac® 2.5ml Vaccine (5 doses)

Rotavirus 116E Live Attenuated+ Oral

Zambia Registered/Compliant

Rotavac® 5.0ml Vaccine (10 doses)

Rotavirus 116E Live Attenuated+ Oral

Zambia Registered/Compliant

TYPBAR TCV

PURIFIED VI-CAPSULAR POLYSACCHARIDE OF TYPHI TY.2 CONJUGATED TO TETANUS TOXOID

Kenya Registered
29 products