Smruthi Organics
Smruthi Organics Ltd is a mid-size, public limited, API manufacturing company from Solapur, India. Smruthi Organics Ltd was established in1989 by qualified technocrats and has very good experience and reputation in the pharmaceutical industry for the supply of quality products.
Their core competency is multi-step organic synthesis and large scale manufacturing of organic molecules. Their focus has always been API for the regulated markets. They have been part of successful contract manufacturing and custom synthesis agreements with leading European, American and Japanese customers. They are currently expanding our R&D to become a one-stop solution provider from concept to execution for all API including, but not restricted to, the following:
Their constant endeavor to improve operations and systems has contributed to our growth. they encourage operational transparency with customers, which complements to confidence building for stronger relationships. Customer satisfaction is their highest priority and they constantly strive on optimizing delivery times of all their services.
Smruthi Organics Ltd facility is USFDA approved and European GMP certified for Carbidopa, Metformin HCL and Norfloxacin. It has successfully filed 4 European and US drug master files for different products.
Smruthi can manage a potential molecule's entire development life cycle up to commercialization through rigorous planning and proper execution. Smruthi can independently or in conjunction with the customer develop optimized synthesis process, perform scale-up and process validations, compile DMF and provide the customer with regulatory support for finished formulation dossier registration. The engagement can be either on an FTE or deliverables basis. We respect absolute confidentiality in such sensitive relationships enhancing smooth exchange of information.
Product range of the company includes:
API
Their core competency is multi-step organic synthesis and large scale manufacturing of organic molecules. Their focus has always been API for the regulated markets. They have been part of successful contract manufacturing and custom synthesis agreements with leading European, American and Japanese customers. They are currently expanding our R&D to become a one-stop solution provider from concept to execution for all API including, but not restricted to, the following:
- Process Development
- Process Optimization
- Process Validation
- Analytical Methods Validation
- Regulatory Support and DMF Registrations
- Commercial Manufacturing
Their constant endeavor to improve operations and systems has contributed to our growth. they encourage operational transparency with customers, which complements to confidence building for stronger relationships. Customer satisfaction is their highest priority and they constantly strive on optimizing delivery times of all their services.
Smruthi Organics Ltd facility is USFDA approved and European GMP certified for Carbidopa, Metformin HCL and Norfloxacin. It has successfully filed 4 European and US drug master files for different products.
Smruthi can manage a potential molecule's entire development life cycle up to commercialization through rigorous planning and proper execution. Smruthi can independently or in conjunction with the customer develop optimized synthesis process, perform scale-up and process validations, compile DMF and provide the customer with regulatory support for finished formulation dossier registration. The engagement can be either on an FTE or deliverables basis. We respect absolute confidentiality in such sensitive relationships enhancing smooth exchange of information.
Product range of the company includes:
API
- Amlodipine Base
- Amlodipine Besilate
- Carbidopa
- Carvedilol
- Chlorhexidine Base
- Chlorhexidine Salts
- Ciprofloxacin HCI
- Clofibrate
- Diloxanide Furoate
- Enrofloxacin
- Fenofibrate
- Fluconazole
- Iopomidol
- Metformin HCI
- Norfloxacin
- Pefloxacin
- S-Amlodipine
- Nabumetone
- Nabumetone
- Iopamidol / Iohexol
- Montelukast
- Iopamidol
- Co-enzyme Q10
- Atorvastatin
- Carvedilol
- Ciprofloxacin/Enrofloxacin
- Perindopril
- The company’s quality systems and facilities are approved by USFDA, EU – GMP and ISO 9001:2000.