Your trusted partner in pharmaceutical development, technology transfer, and regulatory compliance with international standards
Get In TouchWe have extensive expertise in finished drug products development, technology transfer and regulatory dossiers preparation in accordance with international standards. Our team is experienced in addressing regulatory queries and scientific justifications from various Health Authorities including the United States (USFDA), European Union (EMEA/National Agencies), Australia (TGA), New Zealand (Medsafe) and rest of the world (ROW) markets.
We assist our clients by providing a wide range of Active Pharmaceutical Ingredients (APIs) including DMF, Non-DMF and CEP grades as well as Key Intermediates and Reference Standards to support products development and regulatory submissions.
We support our clients by providing a wide range of rare and complex impurities including Nitrosamine and N-Nitroso impurities to facilitate impurity profiling, risk assessment and analytical development in compliance with global regulatory requirements.
With vast experience in the synthesis of complex molecules, we provide in-house pharmacopeial impurities to our clients to fulfill their regulatory requirements. With more than 5000 in-house pharmacopeial impurities in stock confirming the structure against EP/USP/BP reference standards by pharmacopeial HPLC and other pharmacopeial methods and standard characterization methods (UV, FTIR, NMR, LC-MS etc.).
Support for clinical trials including Study Design Evaluation, Pharmacokinetic study and Clinical Data Management. Our end-to-end services covers Synopsis Assessment, Protocol Review, Study initiation, Monitoring, Site closeout and Regulatory Compliance.
| S. No. | Product |
|---|---|
| 1 | Azithromycin - 500mg powder for solution for Infusion |
| 2 | Bortezomib for Injection - 1mg/vial, 2.5mg/Vial, 3.5mg/Vial |
| 3 | Cabazitaxel Solution for Injection - 60mg/3mL |
| 4 | Chlorpromazine Injection - 25mg/mL |
| 5 | Decitabine Injection |
| 6 | Docetaxel Injection - 20mg/mL |
| 7 | Epinephrine Injection - 30mg/30mL |
| 8 | Ganirelix acetate Injection - 250µg/0.5mL |
| 9 | Hydroxyprogesterone caproate Injection - 1250mg/5mL vial |
| 10 | Hydroxyzine Injection - 25mg/mL, 50mg/mL |
| 11 | Medroxyprogesterone Acetate Injection - 150mg/mL |
| 12 | Melphalan Hydrochloride for Injection - 50mg/vial |
| 13 | Methyl Prednisolone acetate - 40mg/mL, 80mg/mL Vial |
| 14 | Milrinone Injection - 1mg/mL |
| 15 | Naloxone HCl Injection - 2mg/2mL PFS |
| 16 | Pantoprazole for Injection - 40mg/Vial |
| 17 | Pemetrexed liquid concentrate for Injection - 25mg/mL |
| 18 | Plerixafor Injection - 24mg/1.2mL (20mg/mL) |
| 19 | Regadenoson Injection - 0.4mg/5mL PFS |
| 20 | Sodium Nitroprusside Injection - 25mg/mL |
| 21 | Zinc Sulphate Injection |
| S. No. | Product |
|---|---|
| 1 | Apalutamide Tablets - 60 mg, 240 mg |
| 2 | Apixaban Tablets - 2.5 mg, 5 mg |
| 3 | Azithromycin Tablets - 500 mg, 250 mg |
| 4 | Baricitinib Tablets - 4 mg, 2 mg, 1 mg |
| 5 | Carbidopa and Levodopa Tablets - 10 mg/100 mg, 25 mg/100 mg, 25 mg/250 mg |
| 6 | Cariprazine Capsules - 1.5 mg, 3 mg, 4.5 mg, 6 mg |
| 7 | Clobazam Tablets - 20 mg |
| 8 | Dapagliflozin Tablets - 5 mg, 10 mg |
| 9 | Empagliflozin and Linagliptin Tablets - 10 mg/5 mg, 25 mg/5 mg |
| 10 | Empagliflozin Tablets - 10 mg, 25 mg |
| 11 | Empagliflozin, Linagliptin and Metformin Tablets - 5 mg/2.5 mg/1000 mg, 10 mg/5 mg/1000 mg, 12.5 mg/2.5 mg/1000 mg, 25 mg/5 mg/1000 mg |
| 12 | Enzalutamide Capsules - 40 mg |
| 13 | Enzalutamide Tablets - 40 mg, 80 mg |
| 14 | Fenofibrate Tablets - 160 mg |
| 15 | Finerenone Tablets - 10 mg, 20 mg, 40 mg |
| 16 | Fingolimod Capsules - 0.5 mg, 0.25 mg |
| 17 | Hydroxyurea Capsules - 500 mg |
| 18 | Ibrutinib Tablets - 140 mg, 280 mg, 420 mg, 560 mg |
| 19 | Isotretinoin Capsules - 8 mg, 16 mg, 24 mg, 32 mg |
| 20 | Lenalidomide Capsules - 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg |
| 21 | Lenvatinib Capsules - 4 mg, 10 mg |
| 22 | Levodopa/Benserazide Tablets - 200 mg/50 mg, 100 mg/25 mg, 50 mg/12.5 mg |
| 23 | Lumateperone Capsules - 10.5 mg, 21 mg, 42 mg |
| 24 | Mirabegron Tablets - 25 mg, 50 mg |
| 25 | Mirtazapine Tablets - 45 mg, 30 mg, 15 mg |
| 26 | Nilotinib Capsules - 50 mg, 150 mg, 200 mg |
| 27 | Olaparib Tablets - 100 mg, 150 mg |
| 28 | Palbociclib Tablets - 75 mg, 100 mg, 125 mg |
| 29 | Pinaverium Bromide Tablets - 50 mg, 100 mg |
| 30 | Pomalidomide Capsules - 1 mg, 2 mg, 3 mg, 4 mg |
| 31 | Sacubitril Valsartan Tablets - 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg |
| 32 | Semaglutide Tablets - 1.5 mg, 4 mg, 9 mg |
| 33 | Semaglutide Tablets - 3 mg, 7 mg, 14 mg |
| 34 | Tadalafil Tablets - 20 mg, 10 mg, 5 mg |
| 35 | Venetoclax Tablets - 10 mg, 50 mg, 100 mg |
| 36 | Vonoprazan Tablets - 10 mg, 20 mg |
| S. No. | Product |
|---|---|
| 1 | Bimatoprost Ophthalmic Solution - 0.021% w/v |
| 2 | Difluprednate Ophthalmic Emulsion - 0.05% w/v |
| 3 | Latanoprost/Timolol Ophthalmic Solution |
| 4 | Loteprednol Etabonate Ophthalmic Suspension - 5mg/mL |
| 5 | Lotilaner Eye Drop Solution - 0.25% |
| 6 | Tobramycin (0.3%) and Dexamethasone Ophthalmic Suspension (0.1%) |
For inquiries and collaborations, please reach out to our key contacts: