API Registration
Param Pharma offers the support for API & Formulation registrations in India ensuring smooth liason between supplier and DCGI for quick and definite approvals.
1. WHO ARE WE & WHAT WE OFFER
Param Pharma is a mumbai based independent consulting professional company run by experts who specialize in providing consulting services on all DCGI related issues. We provide regulatory services to the Indian & International Pharmaceutical Industry for .
New drug approval
API Registration
Biological Registration
Formulation Registration
Medical Device Registration
Cosmetic Products
Clinical Trial Permission
2. WE SPECIALIZED IN HELPING A CUSTOMER TO OBTAIN THE FOLLOWING
- Drugs Registration ( Form 41 )
- Vaccines Registration (Form 41)
- Medical Devices Registration (Form 41)
- Cosmetics Registration (Form 43)
- Neutral Code License
- Import License (Form 10)
- Test License (Form 11)
- New Drug Permission (Form 45)
- Hospital License (Form 12AA)
3. API REGISTRATION
- Requirement : Dossier as per DCGI Guidelines.
- Time Taken : 6 to 8 months
4. FEES
Govt. Fees Structure
- Applicant shall make a payment of 1500 USD (or its equivalent to Indian Currency), as registration fee for the Manufacturing premises.
- Applicant shall make a payment of 1000 USD (or its equivalent to Indian Currency), as registration fee for a single drug and additional fee of 1000 USD for each additional drug in case the manufacturing site remains the same
- So total Government Fees for Registration
- Manufacturer Plant (site) Registration - 1500 USD
- Drug Registration - 1000 USD/ Drugz
5. SCOPE OF THE WORK
- Assisting the preparation of dossier & application
- Getting TR Challan.
- Review of Dossier
- Submission of dossier at DCGI, Delhi
- Query Replies from DCGI
- Updating while testing of drugs at CDTL
- Continuous follow up
- Regular updating
- Maintain Confidentiality & Anti corruption Laws