Marketing Authorisation Holder

Serum Institute Of India

INDIA

Serum Institute Of India, 212/2, off Soli Poonawalla Road, Parijat Colony, Sadhana Society, Hadapsar, Pune, Maharashtra 411028, India

Pune, India

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Dosage Forms

Countries

Tanzania (19) Rwanda (17) Ghana (16) Zimbabwe (12) Zambia (11) Botswana (5)

Location

Serum Institute Of India, 212/2, off Soli Poonawalla Road, Parijat Colony, Sadhana Society, Hadapsar, Pune, Maharashtra 411028, India

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Registration Status

Registered 52

PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 12

Valid 11

3 months to expiry 5

Dosage Forms

Suspension for injection 10 VACCINE 9 Solution for injection 7 Suspension for Injection 6 INJECTION 5 Live freeze-dried vaccine 4 Injection 3 Suspension of injection 2

Local Agents / Applicants

Serum Institute of India Limited 19

SERUM INSTITUTE OF INDIA PVT LTD 12

Serum Institute of India... 11

Serum Institute of India Pvt. Ltd. 6

SERUM INSTITUTE OF INDIA PVT. LTD 6

M & G PHARMACEUTICALS... 6

Registered Medicines

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Product	Form / Strength	Country	Reg. Number	Status
PENTA LIQUID VACCINE Diphtheria Toxoid, Tetanus Toxoid, B. Pertussis, HBsAg (rDNA) and Purified capsular Hib Polysaccharide (PRP) conjugated to Tetanus Toxoid (carrier protein)	Suspension for injection ? 25 Lf (? 30 IU), ? 2.5 Lf (? 40 IU), ? 16 OU (? 4 IU), ? 10 mcg, 10 mcg, ? 1.25 mg, 0.005 %	Rwanda	Rwanda FDA-HBP-MA-0138	Registered
PNEUMOSIL -	Suspension of injection -	Rwanda	RWANDA-FDA25/HM/0163/0035	Registered
PNEUMOSIL PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE 10 VALENT	VACCINE 2MCG/0.5ML;4MCG/0.5ML	Zimbabwe	2025/18.2/7062	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
PNEUMOSIL 0.5ML VACCINE -	INJECTION	Botswana	BOT2203887	Registered/Compliant
PNEUMOSIL 0.5ML-1 DOSE & 2.5ML-5 DOSE PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (ADSORBED) (10 VALENT) PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE	PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE 0.5ML/1 DOSE & 2.5ML/5DOSE	Ghana	FDA/HVC/245-08015	Valid
PNEUMOSIL 2.5ML VACCINE -	INJECTION	Botswana	BOT2203888	Registered/Compliant
POLIOMYELITIS VACCINE ORAL, BIVALENT TYPE 1 AND 3	ORAL, BIVALENT TYPE 1 AND 3 0.1ML/DOSE (20 DOSES)	Ghana	FDA/HVC/255-03004	Valid
POLIOMYELITIS VACCINE (ORAL) BIVALENT TYPE 1 AND 3 20 DOSE Monovalent Bulk of Poliomyelitis Type 1 and 3,	Solution for Oral administration Type 1 and 3 - 20 Dose	Rwanda	Rwanda FDA-HBP-MA-0118	Registered
Pneumococcal Polysaccharide 10 Valent Conjugate Vaccine (adsorbeb) (10-Valent) 1 dose Conjugated to CRM197carrier protein Aluminium (as Aluminium phospahe) 0.125 mg,Saccharide serotype 14 2 mcg,Saccharide serotype 19A 2 mcg,Saccharide serotype 19F 2 mcg,Saccharide serotype 23F 2 mcg,Saccharide serotype 7F 2 mcg,Saccharide serotype 9V 2 mcg,Saccharides for serotype 6B 4 mcg,Saccharides serotypes 1, 5, 9V, 14,19A, 19F, 23F, 7F, 6A 2 mcg,Thiomersal 0.005 %	Suspension for injection	Tanzania	TAN 20 HM 0440	Registered/Compliant
Pneumococcal Polysaccharide Conjugate Vaccine(adsorbed) (10 Valent) 5 dose Saccharide serotype 1 2 mcg,Saccharide serotype 14 2 mcg,Saccharide serotype 19A 2 mcg,Saccharide serotype 19F 2 mcg,Saccharide serotype 23F 2 mcg,Saccharide serotype 5 2 mcg,Saccharide serotype 6A 2 mcg,Saccharide serotype 6B 4 mcg,Saccharide serotype 7F 2 mcg,Saccharide serotype 9V 2 mcg	Suspension for injection	Tanzania	TAN 20 HM 0439	Registered/Compliant
Pneumosil Conjugate Vaccine (10 valent) 0.5 mL Single-dose Vial Pneumococcal polysaccharide serotype 1 2mcg mcg,Pneumococcal Polysaccharide serotype 14 2 mcg mcg,Pneumococcal Polysaccharide serotype 19F 2 mcg mcg,Pneumococcal Polysaccharide serotype 23F 2 mcg mcg,Pneumococcal Polysaccharide serotype 5 2mcg mcg,Pneumococcal polysaccharide serotype 6A 2mcg mcg,Pneumococcal Polysaccharide serotype 6B 4 mcg mcg,Pneumococcal Polysaccharide serotype 7F 2 mcg mcg,Pneumococcal Polysaccharide serotype 9V 2 mcg mcg,Pneumococcal polysaccharide serotype19A 2 mcg mcg	Suspension for Injection 2 mcg mcg,2mcg mcg,4 mcg mcg	Zambia	ZAMRA-HM-25-243	Registered/Compliant
Pneumosil Conjugate Vaccine (10-Valent) 2.5mL Multi-dose Vial Pneumococcal polysaccharide serotype 1 2mcg mcg,Pneumococcal Polysaccharide serotype 14 2 mcg,Pneumococcal Polysaccharide serotype 19F 2 mcg,Pneumococcal Polysaccharide serotype 23F 2 mcg,Pneumococcal Polysaccharide serotype 5 2 mcg,Pneumococcal polysaccharide serotype 6A 2 mcg,Pneumococcal Polysaccharide serotype 6B 4 mcg,Pneumococcal Polysaccharide serotype 7F 2 mcg,Pneumococcal Polysaccharide serotype 9V 2 mcg,Pneumococcal polysaccharide serotype19A 2 mcg	Suspension for Injection 2 mcg,2mcg mcg,4 mcg	Zambia	ZAMRA-HM-25-244	Registered/Compliant
R21 MALARIA VACCINE (RECOMBINANT, ADJUVANTED) 5MCG/0.5ML INJECTION -	INJECTION	Botswana	BOT2404243	Registered/Compliant
R21 MALARIA VACCINE (RECOMBINANT, ADJUVANTED) 5MCG/0.5ML INJECTION -	INJECTION	Botswana	BOT2404243A	Registered/Compliant
RABIVAX -S Purified Rabies Antigen (Rabies virus Pitman-Moore Strain 3218-VERO adapted and grown on vero cells, inactivated by using β - propiolactone) 2.5 IU/ml	Lyophilized Injection	Tanzania	TZ 18 H 0161	Registered/Compliant
RABIVAX-S Purified Rabies Antigen	Lyophilized powder for injection 1 dose of 2.5 IU	Rwanda	RWANDA-FDA25/HM/0237/0008	Registered
RABIVAX-S RABIES VIRUS ANTIGEN (INACTIVATED)	VACCINE NOT LESS THAN 2.5IU	Zimbabwe	2025/18.2/7106	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
RABIVAX-S RABIES VACCINE INACTIVATED (FREEZE-DRIED) 1-DOSE NOT LESS THAN 2.5IU POWDER FOR INJECTION RABIES VACCINE INACTIVATED	RABIES VACCINE INACTIVATED 1-DOSE NOT LESS THAN 2.5IU	Ghana	FDA/HVC/251-07017	3 months to expiry
REPOITIN RECOMBINANT HUMAN ERYTHROPOIETIN	RECOMBINANT HUMAN ERYTHROPOIETIN 2000IU	Ghana	FDA/BS/255-02003	Valid
REPOITIN RECOMBINANT HUMAN ERYTHROPOIETIN	RECOMBINANT HUMAN ERYTHROPOIETIN 4000IU	Ghana	FDA/BS/255-02004	Valid

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