Business Development Services
BUSINESS DEVELOPMENT SERVICES (FINISHED DOSAGES) and REGULATORY SERVICES (BIO AND CLINICAL STUDIES)
FORMULATION DEVELOPMENT
Offering new dosage/strength development (completely non infringing) and /or the known or pre-approved dosage/ strength for any of the following molecule(s)/customer delighted molecule(s) either infringing or non-Infringing shall be developed and provide CDMA catering in various USFDA sites on long run basis.
End to End Project can be executed with Quality by Design of each drug product as per USFDA, EMA, Health Canada, and TGA - Australia
Right from contract research and development from USFDA, EMA, Health Canada approved sites
Clinical research development - Bioequivalence Studies and Clinical Studies from USFDA, EMA, Health Canada approved sites
Technology transfer in USFDA, EMA, Health Canada approved commercial scaled up sites
take up submission or exhibit or validation batches in USFDA, EMA, Health Canada approved commercial scaled up sites
CTD or ANDA dossier development
Obtaining Marketing Authorization in respective regulatory markets through prospective customers or Sponsors and
License and supply of drug product to the end user across the globe
ANDAs of the following product are Filed with USFDA few of them get approved by USFDA
| Drug Research Solutions - Drug Products List | |
|---|---|
| S.NO | Name of the Products |
| 1 | Abiraterone Tablets 250 mg; and 500 mg |
| 2 | Fingolimod Capsules 0.5 mg |
| 3 | Teriflunomide Tablets 7 mg; and 14 mg |
| 4 | Tenofovir Disproxil Fumarate Tablets 150 mg; 200 mg; 250 mg; and 300 mg |
| 5 | Apixaban Tablets 2.5 mg; and 5 mg |
| 6 | Dimethyl Fumarate Capsules 120 mg; and 240 mg |
| 7 | Zileuton Tablets ER 600 mg |
| 8 | Acetazolmide Capsules ER 500 mg |
| 9 | Albuterol Tablets 2 g; and 4 mg |
| 10 | Macitentan Tablets 10 mg |
| 11 | Dapagliflozin Tablets 5 mg; and 10 mg |
| 12 | Pirfenidone Tablets 267 mg; and 801 mg |
| 13 | Metolazone Tablets 2.5 mg; 5 mg; and 10 mg |
| 14 | Eliglustat Tartrate Capsules 84 mg |
| 15 | Rivaroxaban Tablets 10 mg; 15 mg; and 25 mg |
| 16 | Exemestane Tablets 25 mg |
| 17 | Dabigatran Etexilate Mesylate Capsules 75 mg; 110 mg; and 150 mg |
| 18 | Metoprolol Succinate Tablets ER 25 mg; 50 mg; 100 mg; and 200 mg |
| 19 | Naproxen Sodium Tablets ER 375 mg; 500 mg; and 750 mg |
| 20 | Chlorpromazine Tablets 10 mg; 25 mg; 50 mg; 100 mg; and 200 mg |
| 21 | Sevalamer Carbonate Tablets 800 mg |
| 22 | Palbociclib Capsules 75 mg; 100 mg; and 125 mg |
| 23 | Nilotinib Capsules 50 mg; 150 mg; and 200 mg |
| 24 | Erlotinib Hydrochloride Tablets 25 mg; 100 mg; and 150 mg |
| 25 | Sunitinib Malate Capsules 12.5 mg; 25 mg; 37.5 mg and 50 mg |
| 26 | Dasatinib Tablets 20 mg; 50 mg; 70 mg; 80 mg; 100 mg and 140 mg |
| 27 | Sorafenib Tablets 200 mg |
| 28 | Doxazosin Tablets XR 4 mg |
| 29 | Memantine Capsules XR 7mg; 14 mg; 21 mg; and 28 mg |
| 30 | Memantine Hydrochloride Tablets 5 mg; and 10 mg |
| 31 | Mesalamine Tablets Gastro Resistant 500 mg |
| 32 | Budesonide Tablets ER 9 mg |
| 33 | Dolutegravir + Lamivudine + Tenofovir Disoproxil Fumarate Tablets 50 mg + 300 mg + 300 mg |