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.

= Available for reference   |   = Granted   |    = Ready   |   = Filed   |   = Registered   |   = Available
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 1000 Learn More
Ibuprofen Lysinate NSAID 57469-76-8 600* - - - - Learn More
Ibuprofen Sodium NSAID 31121-93-4 800* - - - - - Learn More
Dex-Ibuprofen NSAID 51146-56-6 200* - - - - - - Learn More
Metformin HCL Anti-Diabetic 1115-70-4 1500 Learn More
Clopidogrel Bisulphate (Form II) Anti-Platelet 120202-66-6 550 Learn More
Pantoprazole Sodium Proton Pump Inhibitor 164579-32-2 500 Learn More
Fenofibrate (Micronised) Anti-Cholesterol 49562-28-9 550 Learn More
Gabapentin Anti-Convulsant 60142-96-3 700 - Learn More
Lamotrigine Anti-Convulsant 84057-84- 165* Learn More
Losartan Potassium Anti-Hypertensive 124750-99-8 400 - - Learn More
Levetiracetam Anti-Epileptic 102767-28-2 250* - Learn More
Paracetamol Analgesic & Antipyretic 103-90-2 1500 - - Learn More
Learn About Ibuprofen & its derivatives     Learn About our new products
Product Name Therapeutic Category CAS No. Under Development Under Validation
Quetiapine Fumarate Anti-Psychotic 111974-72-2 Completed Completed
Allopurinol Xanthine Oxidase 315-3-0 Completed Completed
Irbesartan Anti-Hypertensive 138402-11-6 Completed tik
Valsartan Anti-Hypertensive 137862-53-4 Completed tik
Vildagliptin Anti-Diabetic 274901-16-5 Completed tik
Sitagliptin M Phosphate Anti-Diabetic 654671-77-9 Completed tik
Minoxidil Anti-Hypertensive 38304-91-5 tik -
Mesalazine Anti-Inflammatory 89-57-6 tik -
Ketoconazole Azole Antifungals 65277-42-1 tik -
Sacubitril Neprilysin Inhibitor 149709-62-6 tik -
Edoxaban Oral Anticoagulant 480449-70-5 tik -
Product Name CAS No. API
L- Prolinamide Hydrochloride 42429-27-6 Vildagliptin
3- Amino-1-adamantanol 702-82-9 Vildagliptin
3- (Trifluoromethyl)-5,6,7,8-tetrahydro [1,2,4] Triazolo[4,3-a]pyrazine Hydrochloride 762240-92-6 Sitagliptin
Sitagliptin Ketoamide 764667-65-4 Sitagliptin
4- Chloro-4’-hydroxybenzophenone 42019-78-3 Fenofibrate
L- Valine methyl ester Hydrochloride 6306-52-1 Valsartan
Coupled Amine Hydrochloride 141109-19-5 Clopidogrel
4- Chloro-3-methoxy-2-methylpyridine 107512-34-5 Pantoprazole
Azacyclonol 115-46-8 Fexofenadine
4- Isobutylacetophenone 38861-78-8 Ibuprofen
2-(2,3-Dichlorophenyl)-2-Guanidinylimino Acetonitrile (Schiff’s base) 84689-20-3 Lamotrigine
2-Azaspiro[4.5]decan-3-one (Lactum) 64744-50-9 Gabapentin
Para amino phenol (PAP) 123-30-8 Paracetamol
API Regulatory Affairs in Pharmaceutical Industry