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API Registration

Anantco 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

Anantco 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)
  • Import License (Form 10)
  • Test License (Form 11)
  • New Drug Permission (Form 45)
  • Hospital License (Form 12AA)
  • Blood Bank and Blood Product Registration
  • NOC for Import of Half finished or Raw materials.
  • Loan License
  • Legalization of Export/Import documents
  • Neutral Code License
  • Any other Organizational Clearances say Animal Husbandry, Diary Products Etc
  • Information Regarding any types of Queries under Drug Rules & Custom Rules.

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