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