Sakar has a robust infrastructure for carrying out research and development covering multiple therapeutic categories including analgesic, antipyretic, antibiotics, vitamins, caugh expectorants. A team of well trained scientists, who has over two decades of comprehensive industry experience, are exploring various options in-house in field of Research & Development. The team performance with encouraging outcomes has been recognised by Department of Scientific & Industrial Research (DSIR)under Ministry of Science & Technology, India. With proven expertise and recognition, Sakar further looks forward to opportunities pursuing researches with oncology products.
Comprehensive up-to-date Oncology R & D, ADL and F & D laboratories to partner services which include:
It is a pleasure to introduce Sakar’s new technology enhanced state of the art research driven oncology integrated pharmaceuticals manufacturing unit. The standalone unit includes
- Research Laboratories (F&D, R&D, ADL)
- Manufacturing unit for oral solid dosages (tablet, capsule)
- Set up for manufacturing injections (liquid, lyophilised)
- Unit for manufacturing potent APIs
With the onset of the Research Laboratories, Sakar looks forward to manage expensive highly potent products and processes ensuring regulatory norms. The Lab will ensure process standardization through advanced Flow-chemistry based techniques for synthesis of APIs and Specialty products. The processes adopted will verify the Green Chemistry techniques in API synthesis in a cost effective manner.
The equipment systems have been designed to develop and prepare latest formulations / dosage forms with advance techniques like continuous flow technology.
The labs have been suitably equipped to ensure in-house competitiveness and deliver best partnered services:
- Chemical synthesis services for API intermediates and speciality chemicals through batch type and AI integrated flow chemistry based operation system with modern analytical back up facilities
- Initial phase contract development services can be offered in containment facilities designed for HPAPI, comprising of laboratory scale process development, non-infringing studies, impurities identification, isolation and characterization, analytical method devolvement, accelerated stability studies and process validation with complete documentation (PDR) as per QBD concept for Lab development products
- Next phase scale up studies with impurity profiling, stability studies, risk analysis studies and production from gram scale to kilo scale with all cGMP documentation in HPAPI containment area. Validation batches can be offered for both formulation devolvement as well as clinical trials
- Comprehensive Process development, analytical development, stability studies offer for finished dosages in contained formulation development lab. Formulation development studies as per the QBD Concept with complete documentation and PDR for any new drug delivery system for Solid dosage, liquid injection and lyophilised molecules.
- Process Capabilities of formulation Sterile Injectable with simple solution to Lyophilized technology, to complex generic e.g. Lipid and peptide, in non sterile OSD dry and wet granulation (aqueous and non aqueous) to Fluid bed technology to pellet coating/drug layering, encapsulation, compression, coating and finished packing.
- Process Capabilities of synthetic oncology flow chemistry, multistep synthesis, hydrogenation, halogenations, sulphonation, Oxidation reaction, chiral separation, cryo reaction, polymorphic etc from gm to kg level.
- Pilot plant validation batches taken up for technology transfer with subsequent scaling up of finished formulations- solid, liquid injection & lyophilised injection in contained lines
The comprehensive unit will be a one-stop solution for organization operating in the similar therapeutic range with flexibility and customization for all possible services.