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info@delexcel.com
Research & Development at DelExcel Pharma
Our state-of-the-art R&D facility is designed to drive innovation and deliver high-quality pharmaceutical products. Our R&D team focuses on the development of solid oral dosage forms and other advanced drug delivery technologies, ensuring that our products meet global regulatory standards while addressing unmet medical needs. With dedicated infrastructure for non-potent and potent product development, we are well-equipped to handle a wide range of research projects, from early-stage formulation development to commercial manufacturing.
Key Capabilities
Formulation Development
Our R&D facility is equipped to handle the development of both non-potent and potent/cytotoxic products. We offer state-of-the-art, linear scale-up equipment for oral solid dosage forms, with batch sizes ranging from 0.25 kg to 10 kg for non-potent products and up to 5 kg for potent formulations. This allows us to optimize formulations for immediate release, modified release, and sustained release applications.
Analytical Development & Stability Testing
Our analytical development laboratories are equipped with modern instruments, including 6 HPLCs and walk-in stability chambers (9600 liters), which ensure precise analytical testing and long-term product stability. We have the capacity to accommodate up to 42 HPLCs, supporting the rigorous testing required for product development and regulatory compliance.
Per-Oral Drug Delivery Technologies
We specialize in a variety of advanced drug delivery technologies, including:
- Modified Release Technologies: Gastro-resistant systems, colonic systems, and multi-particulate systems.
- Sustained Release Technologies: Matrix diffusion, erosion-controlled systems, and osmotic systems.
- Rapid Dissolving/Action Technologies: Orally disintegrating formulations for faster release and enhanced bioavailability.
List of Products
Ready for Technology Transfer
| S.No | Product Name |
|---|---|
| 1 | Esomeprazole Gastro-Resistant Tablets 20mg & 40mg (MUPS) |
| 2 | Metoprolol Succinate Extended Release Tablets 25 and 50 mg (MUPS) |
| 3 | Sitagliptin Tablets 25, 50, and 100 mg |
| 4 | Apixaban Tablets 2.5mg and 5mg |
| 5 | Ursodeoxycholic Acid Tablets (150mg, 250mg & 500mg) |
| 6 | Ursodeoxycholic Acid Capsules (250mg, 300mg & 450mg) |
| 7 | Abiraterone Acetate Tablets 250mg & 500mg |
| 8 | Capecitabine Tablets 150mg & 500mg |
| 9 | Procyclidine Tablets 2.5, 5 & 10mg |
| 10 | Guanfacine HCl ER Tablets 1,2,3 & 4mg |
| 11 | Doxylamine Succinate and Pyridoxine HCl Tablets 10mg/10mg |
| 12 | Pentoxifylline Sustained Release Tablets 400mg |
| 13 | Linagliptin Tablets 5mg |
| 14 | Linagliptin and Metformin HCl Tablets 2.5/500, 2.5/850 and 2.5/1000mg |
| 15 | Sitagliptin and Metformin HCl Tablets 50/500, 50/850 mg, and 50/1000 mg |
| 16 | Edoxaban Tosylate Tablets 15, 30 and 60mg |
| 17 | Empagliflozin Tablets 10 and 25mg |
| 18 | Empagliflozin and Metformin HCl Tablets 5/500, 5/1000, 12.5/500 and 12.5/1000mg |
| 19 | Fingolimod Capsules 0.25mg and 0.5mg |
| 20 | Solifenacin and Tamsulosin HCl modified release Tablets 6/0.4mg |
| 21 | Naftidrofuryl Oxalate capsules 100mg |
| 22 | Saccubitril-Valsartan Film Coated Tablets 24mg/26mg, 49mg/51mg, 97mg/103mg |
| 23 | Propranolol HCl Extended Release Capsules 60, 80, 120 & 160mg |
| 24 | Telmisartan Tablets 40mg and 80mg |
| 25 | Telmisartan and Amlodipine Tablets 40/5, 40/10, 80/5 and 80/10mg |
| 26 | Naltrexone 8mg and Bupropione 90mg Extended Release Tablets |
| 27 | Tolvaptan Tablets 7.5, 15, 30, 45, 60 and 90mg |
| 28 | Telmisartan and Hydrochlorothiazide Tablets 40/12.5, 80/12.5 and 80/25mg |
Development Work Completed
| S.No | Product Name |
|---|---|
| 1 | Paroxetine HCl Enteric-Coated Sustained-Release Tablets 12.5mg & 25mg |
| 2 | Tolterodine L-Tartrate Sustained Release Capsules |
| 3 | Compound Sodium Valproate and Valproic acid SR Tablets 500mg |
| 4 | Atorvastatin Calcium Tablets 10, 20 and 40mg |
| 5 | Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10, 2.5/20, 2.5/40, 5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40 and 10/80mg |
| 6 | Montelukast Sodium Tablets 10mg |
| 7 | Montelukast Sodium chewable Tablets 4mg and 5mg |
| 8 | Rosuvastatin Calcium Tablets 5, 10, 20 and 40mg |
| 9 | Irbesartan capsules 150mg |
| 10 | Olanzapine Orodispersable Tablets 5mg & 10mg |
| 11 | Candesartan Tablets 4mg, 8mg & 16mg |
| 12 | Aspirin Delayed Release Tablets 25mg and 100mg |
| 13 | Lansoprazole Delayed Release Orally Disintegrating Tablets 15mg & 30mg |
| 14 | Quetiapine Fumarate Extended Release Tablets 50mg, 200mg & 300mg |
| 15 | Efavirenz/ Lamivudine/ Tenofovir Disoproxil Fumarate Tablets 400/300/300mg |
| 16 | Efavirenz/ Lamivudine/ Tenofovir Disoproxil Fumarate Tablets 600/300/300mg |
| 17 | Telmisartan, Amlodipine and Hydrochlorothiazide Tablets 20/2.5/6.25, 20/2.5/12.5, 40/5/12.5 and 80/10/25mg |
End-to-End Development Approach
Our R&D process follows a well-defined, integrated approach, covering every stage from initial concept to commercial scale production. This includes:
- Early Development & Compatibility Studies: Initial testing for formulation compatibility and proof-of-concept.
- Process Optimization: Ensuring scalable, efficient manufacturing processes for both clinical and commercial batches.
- Technology Transfer: Seamless transfer from R&D to pilot plant and full-scale manufacturing, ensuring that the integrity of the formulation is maintained.
- Regulatory Support: Assistance with regulatory submissions and dossier preparation to ensure compliance with global standards.
Why Choose DelExcel Pharma for R&D?
- Comprehensive Expertise: From early formulation to commercial scale, we offer a full suite of R&D services.
- State-of-the-Art Facility: Our facility is equipped with the latest technologies to ensure top-quality research and development.
- Tailored Solutions: We provide flexible, customized solutions to meet the specific needs of our clients.
- Experienced Team: Our highly qualified R&D team has extensive experience in developing innovative pharmaceutical products that exceed industry standards.
