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REGULATORY

REGULATORY

Expertise to lead

The Regulatory Affairs team at SAPTAGIR comprises of seasoned professionals with expertise in the regulatory framework of established global authorities and well-versed in the filing of dossiers, DMFs, CEPs for regulated and semi-regulated markets.

Accreditations

WHO_GMP

WHO-GMP

DUNS & FEI

DUNS# 86-199-1500
FEI# 3016470054

EDQM

EDQM

ICH

ICH

ISO

ISO

Commercial APIs

S.No.ProductCAS NumberTherapeutic Category

Regulatory Documents

1Terbinafine HCl91161-71-6Anti-FungalCEP filed
2Camphor76-22-2Anti-InfectiveDMF
3Ezetimibe163222-33-1Anti-HyperlipidemicASMF Filed
4Solifenacin Succinate242478-38-2Urinary AntispasmodicDMF
5Prasugrel HCl150322-43-3Anti-PlateletDMF
6Triclabendazole68786-66-3Anti-FungalTech-Pack
7Isoniazid54-85-3Anti-TuberculosisTech-Pack
8Tafamidis Meglumine951395-08-7Anti-ArrhythmicsUnder development
9Edoxaban480449-70-5Anti-CoagulantUnder development
10Lasmiditan439239-90-4Anti-MigraineUnder development

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Product Enquiry

CAS Number : 65473-13-4