Facilities

Regulatory Affairs


The Regulatory Affairs Department at MHPL keeps the track of ever-changing scenario and regulations in the pharmaceutical market. worldwide.

We have a competent regulatory department with qualified & experienced personnel who prepare dossiers in Country Specific, ACTD /CTD formats as per the guidelines of Ministry of Health of different countries.

Dossiers are prepared as per required format and regulations which complies to the regulatory standards necessary for Export Registration. Number of dossiers has been submitted in different countries.


DOSSIER SUBMISSIONS

  • AfricaGhana, Nigeria, Burkina Faso, Tanzania, Liberia, Sierra Leone, Mozambique, Ivory Coast
  • AsiaMyanmar, Vietnam, Cambodia, Sri Lanka, Yemen, UAE
  • CIs ZoneUzbekistan, Kyrgyzstan & Azerbaijan
  • Central & South AmericaNicaragua, Guatemala & Bolivia

Registered Products

No Country Products Registered
1 Nigeria 34
2 Ghana 35
3 Burkina Faso 5
4 Tanzania 4
5 Liberia 2
6 Myanmar 12
7 Vietnam 7
8 Nicaragua 10
9 Bolivia 3
Total 112

Submitted Products

No Country Products Submitted
1 Nigeria 15
2 Myanmar 11
3 Vietnam 3
4 Nicaragua 6
5 Guatemala 12
6 Kyrgyzstan 2
Total 49

Products Under Registration

No Country Products Submitted
1 Myanmar 30
2 Uzbekistan 10
3 Azerbaijan 2
4 Cambodia 3
5 Sri Lanka 6
Total 51