API Regulatory Affairs in Pharmaceutical Industry
Under our API vertical, we research, develop and provide various essential products that are used by pharma companies across the world to make key medicines that are essential for humankind. Through our innovation-oriented and research-led approach, we are focusing on generic product development. Furthermore, our team work effortlessly to ensure cost effective commercialisation of our products. Presently, we have commercialised various APIs and several new APIs are in the advanced stage of development.
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| Products | Therapeutic Category | CAS No. | Std. Batch Size(kg) | USDMF | KFDA | CEP | MOH Russia | EUWC | WHO GMP | DMF/ Tech Pack | Click Below |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ibuprofen | NSAID | 15687-27-1 | 3000 | Learn More | |||||||
| Ibuprofen Lysinate | NSAID | 57469-76-8 | 1000* | - | - | - | Learn More | ||||
| Ibuprofen Sodium dihydrate | NSAID | 727688- | 850* | - | - | - | Learn More | ||||
| Dex-Ibuprofen | NSAID | 51146-56-6 | 1000* | - | - | - | Learn More | ||||
| Metformin HCL | Anti-Diabetic | 1115-70-4 | 1500 | Learn More | |||||||
| Clopidogrel Bisulphate (Form II) | Anti-Platelet | 120202-66-6 | 1000* | - | Learn More | ||||||
| Pantoprazole Sodium | Proton Pump Inhibitor | 164579-32-2 | 750* | - | Learn More | ||||||
| Fenofibrate (Micronised) | Anti-Cholesterol | 49562-28-9 | 750 | - | Learn More | ||||||
| Paracetamol | Analgesic & Antipyretic | 103-90-2 | 5000 | - | Learn More | ||||||
| Lamotrigine | Anti-Convulsant | 84057-84-1 | 600* | Learn More | |||||||
| Losartan Potassium | Anti-Hypertensive | 124750-99-8 | 1000* | - | Learn More | ||||||
| Levetiracetam | Anti-Epileptic | 102767-28-2 | 750* | - | Learn More | ||||||
| Paracetamol | Analgesic & Antipyretic | 103-90-2 | 1500 | - | Learn More | ||||||
| Allopurinol | Xanthine Oxidase | 315-3-0 | 600* | - | - | Learn More |
| Product Name | Therapeutic Category | CAS No. | Under Development | Under Validation |
|---|---|---|---|---|
| Quetiapine Fumarate | Anti-Psychotic | 111974-72-2 | Completed | Completed |
| Valsartan | Anti-Hypertensive | 137862-53-4 | Completed |
 |
| Vildagliptin | Anti-Diabetic | 274901-16-5 | Completed |
|
| Sitagliptin M Phosphate | Anti-Diabetic | 654671-77-9 | Completed |
|
| Edoxaban | Oral Anticoagulant | 480449-70-5 |
|
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| Valsartan Sacubitril | Neprilysin Inhibitor | 936623-90-4 | Completed | Completed |
| Fenofibrate Choline | Antilipemic-agent | 886676-23-8 | Completed | - |
| Clopidogrel Besylate | Antiplatelet | 744256-69-7 | Completed | Completed |
| Apixaban | Anti-Coagulant | 503612-47-3 | Completed | Completed |
| Product Name | CAS No. | API |
|---|---|---|
| (S)-Methyl 2-(2-chlorophenyl)-2-((thiophen-2-yl)ethyl)amino acetate hydrochloride (Coupled amine hydrochloride) | 141109-19-5 | Clopidogrel |
| 2-(2,3-Dichlorophenyl)-2-guanyliminoacetonitrile (Schiff's Base) | 84689-20-3 | Lamotrigine |
| 2,4-Diamino-6-hydroxypyrimidine (KSM) | 56-06-4 | Minoxidil |
| 2,4-Diamino-6-chloropyrimidine (2,4-DACP) | 156-83-2 | Minoxidil |
| 2,4-Diamino-6-chloropyrimidine 3-N-Oxide | 35139-67-4 | Minoxidil |
