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Biotech APIs / Formulations

Generics for Regulated Markets

 

Chemical Synthesis APIs

APIs

Specifications

Regulatory Status

ONCOLOGY

Anastrazole

In-house

Tech.Package

Exemestane

In-house

Tech.Package

Mercaptopurine

U.S.P.

US DMF filed / Tech.Package

IMMUNOSUPPRESSANT

Azathioprine

U.S.P. / B.P ./  Ph.Eur.

US DMF filed / C.O.S. / EDMF  - CTD Format

ANTI-PSYCHOTIC

Aripiprazole

In-house

Tech.Package

Haloperidol

B.P. / U.S.P. / Ph.Eur.

C.O.S. / EDMF   - CTD Format

Haloperidol Decanoate

B.P. / Ph.Eur.

Tech.Package

Risperidone *

B.P. / Ph.Eur.

C.O.S. / EDMF - CTD format

ANTI-THROMBOTIC

Clopidogrel Bisulfate (Form I)

U.S.P.

Tech.Package

Ticlopidine Hydrochloride

B.P. / Ph.Eur.

C.O.S. / EDMF - CTD format

OTHERS

Diphenoxylate Hydrochloride

B.P. / U.S.P./ Ph.Eur.

C.O.S. / EDMF - CTD format

Anti-diarrhoeal

Donepezil Hydrochloride

In-house

Tech.Package

Anti-alzheimer

Lamotrigine

In-house

EDMF  - CTD Format

Anti-convulsant

Lercanidipine

In-house

Tech.Package

Anti-hypertensive

Nicorandil

In-house

EDMF - CTD format

Anti-anginal

Propantheline Bromide

B.P. / Ph.Eur.

Tech.Package

Anti-spasmodic (Peptic Ulcer)

Quinfamide

In-house

Tech.Package

Anthelmintic/anti-amoebic

Sertraline Hydrochloride

In-house

EDMF available /Tech. Package

Anti-depressant

Products under Development

APIs

Category

Irinotecan   

Oncology

Letrozole

Oncology

Topotecan

Oncology

Ivabradin Hydrochloride

Anti-anginal

Olmesartan Medoxomil

Anti-hypertensive

Conivaptan

Hyponatremia

 

Note:

The Importer should check for patent status in the country of import.  We do not accept any responsibility for Patent.

*  Process Patent granted in few countries

 

 

Chemical Synthesis APIs

Generics for Regulated Markets

 

Biotech APIs / Formulations

API's

Regulatory Status

ONCOLOGY

Daunorubicin Hydrochloride

US DMF Tech. Grade filed

Doxorubicin Hydrochloride

US DMF & COS filed

Epirubicin Hydrochloride

Tech. Package

Idarubicin Hydrochloride

Tech. Package

Zorubicin Hydrochloride

Tech. Package

IMMUNOSUPPRESSANT

Cyclosporin A

Tech. Package

Sirolimus

Tech. Package

CARDIOLOGY

Eplerenone

Tech. Package

Spironolactone

Tech. Package

Products Under Development

API's

Category

Pirarubicin

Oncology

Vincrystin

Oncology

Mycophenolate Mofetil

Immunosuppressant

Tacrolimus

Immunosuppressant

Orlistat

Anti-obesity

Daptomycin

Antibiotic

Micafungin

Antifungal

 

Formulation

Strength

Packing

Doxorubicin Hydrochloride

10 mg  & 50 mg

Lyophilised Vials

Epirubicin Hydrochloride

10 mg  & 50 mg

Lyophilised Vials

Cyclosporin Capsules

25 mg, 50 mg & 100 mg

10 strips of 5 soft gelatin capsules

Cyclosporin Oral Solution

50 ml (100 mg / ml)

1 Bottle + calibrated Syringe

 

Note:                                                                                                                             

The Importer should check for patent status in the country of import.  We do not accept any responsibility for patent.

 

 

Chemical Synthesis APIs

Biotech APIs / Formulations

 

Generics for Regulated Markets

Product

Regulatory Status

Azathioprine Tablet

Dossier CTD format 

Lamotrigine Tablet

Dossier CTD format 

Sertraline HCl Tablet

Dossier CTD format 

 

Generics Under Development for Regulated Markets

Cyclosporin Soft Gel Capsule

Product Developed - Formulation Patent Granted for USA, Australia, Mexico & South Africa

 

Mycophenolate Mofetil Tablet

Risperidone Tablet

Anastrazole Tablet

6-Mercaptopurine Tablet 

Orlistat Capsule

 

 

 

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