Regulatory Affairs

Our regulatory team is well trained to comply with regulatory requirements for filing and supporting Drug Master Files for the products developed in the Research & Development center.
 
The company has over 30 regulatory filings to it’s credit with regulatory authorities of USA, EU, Japan, Australia, Canada and several other countries
The team regularly interacts with country specific regulatory authorities to ensure appropriate compliance
The team supports customers for regulatory submissions and responding to regulatory queries in a timely manner

 

PRODUCTS

QUALITY
STD.

THERAPEUTIC CATEGORY

TECH.
PACK

REGULATORY STATUS

US
DMF

 EU
EDMF

EU
CEP

JP PDMA

CA
DMF

AUS TGA

Human Use

Cinacalcet HCl

IHS

Anti-hypeparathyroidism

√        

Darifenacin HBr

IHS

Overactive Bladder

 √        

Desvenlafaxine Succinate

 IHS

Anti-depressant

 √        

Donepezil HCl Form I

 IHS

Anti-alzheimer’s

√    

Donepezil HCl Form III

 IHS

Anti-alzheimer’s

√          
Memantine HCl IHS Anti-alzheimer’s √            

Mirtazapine Anhydrous

USP / EP / IP

Anti-depressant

√

        

Mirtazapine Hemihydrate

USP / EP / IP

Anti-depressant

√

  

Quetiapine Hemifumarate

IHS / IP

Anti-schizophrenia

√

        

Solifenacin Succinate

IHS

Overactive Bladder

 √        

Venlafaxine HCl

EP

Anti-depressant

 √      

Ziprasidone HCl

IHS

Anti-schizophrenia

 √        

Veterinary Use

Morantel Citrate

IHS

Anthelmintic

 √            

Morantel Tartrate

IHS

Anthelmintic

 √            

Oxantel Pamaote

IHS

Anthelmintic

 √        

Pyrantel Pamoate (Embonate)

USP / EP / IP

Anthelmintic

 √    

Pyrantel Tartate

B Vet

Anthelmintic

 √        

 

Note: "IHS" - In House Specifications  "U/C" - Under Compilation

Note: Products protected under specific patents in certain countries are not offered for sale by us in such countries.