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 40 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.

CATEGORY

REGULATORY STATUS

Commercial     Tech pack US DMF EUROPE EDMF EU CEP JAPAN PDMA CANADA DMF AUS TGA
 
 
 
For Human Use
Bosentan Monohydrate IHS Arterial hypertension        

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

JP / IHS

Anti-alzheimer’s

         

Mirtazapine Anhydrous

USP / EP / IP

Anti-depressant

   
Mirtazapine Hemihydrate USP / EP / IP Anti-depressant        

Paliperidone

IHS

Anti-schizophrenia

       

Quetiapine Hemifumarate

IHS / IP

Anti-schizophrenia

       

Solifenacin Succinate

IHS

Overactive Bladder

       

Venlafaxine HCl

EP

Anti-depressant

     

Ziprasidone HCl

IHS

Anti-schizophrenia

     

For Veterinary Use

Morantel Citrate

IHS

Anthelmintic

            Note:
"IHS" In-house Specs.

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

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.