Research & Development
Objectives
Development of NDDS (Novel Drug Delivery System).
Development of non infringing process.
New process development for cost effectiveness.
Trouble shooting in the various plants .
Performance batches.
Bioequivalence and bioavailability as per DCGI (Drug Controller General of India) and International guidelines.
Drug regulatory affair and documentation: Dossiers for ANDA’s( Abbreviated New Drug Application) of different countries, NDA's (New Drug Application) filing in India, patents filing after a thorough scrutiny by attorneys, documentation for getting USFDA, documentation for R & D products, documentation for commercial samples, documentation for bioequivalence samples.
Contract Research from conceptualization till the final dossier of the product.
Achievements
Pocketed two patent of Clarithromycin & Fexofenadine.
Taste masking technology of macrolides for the first time in India.
Development of NDDS for old and new molecules.
Developing non infringing process of four products.
Unique tablet in tablet technology.
Development of sustained release process of Isoxsuprine HCL tablets first time in India.
Researching such ayurvedic medicinal plants which show a promise in treating chronic ailments, conditions and life style disorders.
Development of mouth dissolving tablet technique.
Development of Netazoxanide based formulations single & in combination with ofloxacin, first in the country.
Received US and EU patent for Extended Release dosage form of Clarithromycin.
Received European patents for the taste masked formulations of Fexofenadine for pediatrics.
Developed tasteless, directly compressible, fast dissolving, Fexofenadine carboner complex to be used in all solid dosage form of fexofenadine for all age groups .
Developed soluble and stable Macrolide citrate salts to be used in all solid dosage form of Macrolide especially in modified release forms.
Developed Netazoxanide an Anti-diarrheal drug for the first time in India after successful clinical trials and Bioequivalence studies.
Development of Once Daily (OD) of Clarithromycin.
Development of liquid Preparation of Fexofenadine .
Future Plans
To be Recognized as a Research oriented Organisation.
Targeting New Chemical studies, Novel Drug Delivery System.
To Conduct Bio- Equivalence.
Dossier preparation in CTD (Common Technical Document) format.
Stability data Profiling.