Regulatory Excellence
DOSITEC PHARMA operates globally recognized facilities, that are USFDA-approved and have been audited and validated by various international regulatory agencies.
Global Production Leadership
- Montelukast: We are the world’s largest producer with an annual capacity of 60 MT.
- Loratadine: We hold over 90% of the generic market share in the US with a production capacity of 150 MT annually.
- Atorvastatin: Recognized as a leading manufacturer of this blockbuster drug, with a significant global market size.
Commitment to Innovation and Quality
At DOSITEC PHARMA, our goal is to provide high-quality generic drugs at competitive prices by leveraging our deep industry experience, state-of-the-art technology, and robust operational capabilities.
- Product Development: We are actively preparing dossiers in eCTD format to facilitate new product launches, ensuring seamless material and documentation supply.
- Extensive Portfolio: We manufacture over twenty blockbuster APIs under strict cGMP guidelines at our facilities, holding more than 38 active process patents.
- Innovative R&D: Our focus continues developing over 25 new molecules with advanced non-infringing processes aimed at both diabetic care and broader therapeutic areas.
Manufacturing Excellence
Masulkhana Facility
Location: Parwanoo, Himachal Pradesh, India
- Annual Production Capacity: 1000 MT
- Spanning 7 acres with advanced manufacturing standards.
- US FDA and WHO GMP certified with an award-winning R&D centre.
Baddi Facility
Location: Himachal Pradesh, India
- Annual Production Capacity: 1500 MT
- Located over 60 acres, featuring state-of-the-art manufacturing capabilities.
- US FDA and WHO GMP certified with an award-winning R&D centre.
Market Reach
Regulated Markets:
Since 1984, DOSITEC PHARMA has been dedicated to manufacturing high-tech bulk drugs for international markets, enjoying approvals from the USFDA and WHO GMP.