Sambi Pharma offers a broad range of contract research services which are forward integrated with our API services. All carried out at our state-of-the-art research center. Our team is composed of highly motivated scientists who trained at prestigious universities across the world. Our experienced team can perform a wide range of chemistry services such as:
This is possible due to our State-of-the-art infrastructure.
The invention of a new medicine is a marathon process, it requires endurance and commitment. On average it takes at least ten years and an estimated cost of $ 2.6 billion for a new medicine to complete its journey from initial discovery to the commercial marketplace.
Route scouting and enabling technologies all play a key role in the API drug development process to provide new routes that are shorter, safer, cost-effective, sustainable, and have a lower impact on the environment.
Sambi pharma’s route scouting team consists of highly motivated scientists with high caliber scientific knowledge who are trained at renowned universities and big pharma companies across the world. Our route scouting team offers services for
Process development plays vital role in the manufacture of APIs (NCEs and generic).
Sambi Pharmaceutical’s fully-equipped process research and development lab allows rapid development of scalable and robust chemical processes utilizing advanced methodologies. Sambi Pharmaceutical is also equipped with a kilo lab for a quick supply in the early phase of the development.
Our top notched scientists are experts to develop the robust process using PROCESS principles such as Proven, Repeatable, Owner driven, Compatible, Executable, Sustainable, Successful and also SELECT principles such as Safety, Environment, Legal, Economics, Control and Throughput. Our scientists are also experts to develop the sustainable process using GCbD (Green Chemistry by Design).
Sambi Pharmaceutical aims to be a leading player in custom chemical synthesis by providing the most comprehensive product range of innovative products, and by enabling technologies for chemical research. We are specialized in designing cost-effective synthetic routes, handling complex chemical synthesis (over 50 chemical steps) that require fast turnaround times, and developing scalable, sustainable, and safer processes. All our services are carried out with a focus on delivering your required quantity with superior quality and within agreed delivery times.
We follow the PROCESS principles, SELECT principle and GCbD principle to develop a robust and scalable process for your targets in custom synthesis.
We aim to attain the status of a global leader for developing a novel route or non-infringing route for APIs.
Sambi Pharmaceutical’s API division, with their unique expert route scouting team, offers the development of novel synthetic routes or non-infringing routes for off-patent APIs. If customers are looking for off-patent APIs with competitive cost and quality, then our route scouting team can collaborate with customers to identify opportunities early and work closely with them to ensure timely availability of APIs to support their filings and ensure timely market entry.
Impurities are unwanted products that remain with active pharmaceutical ingredients (APIs) and medicines. The presence of these impurities even in trace amounts may influence the efficacy and safety of pharmaceutical products. Identification and quantification of these impurities (Impurity Profile) are now becoming an important critical product quality parameter and are getting critical review from regulatory authorities. Because of this, the limit and threshold values for impurities are specified by pharmacopeias and ICH guidelines. Analysis of impurities according to this set of specifications is mandatory for the pharmaceutical product release for human consumption. Impurity Profile study is also incredibly important for market approval and for finished dosage forms from regulatory authorities.
The identification and quantification of impurity in pharmaceutical products are carried out by using certified impurity standards of known purity. It is recommended to use an impurity standard of >90% purity when used for peak identification in the chromatogram or use in the system suitability test for resolution, and a minimum of 95% purity when used to estimate the content of a specified impurity.
Sambi Pharmaceuticals offers a wide range of high purity and impurity standards for pharmaceutical industries on the mg to kg scale at competitive prices. Sambi Pharmaceuticals has a technical capability to synthesize, isolate, and purify the impurity standards to their purest form. Sambi Pharmaceuticals can also offer the impurity standards from mg to gm scale.
Sambi Pharmaceuticals offers custom synthesis of mg to gm level of impurity compounds on requests. In case of non-standard impurity, the standard additional study for structure elucidation, characterization, and analytical method validation are also undertaken using elemental analysis and state-of-the-art equipment like; LC-MS, HPLC, 1 H and 13 C NMR, FT-IR.