Active Pharmaceutical Ingredients (APIs) form the nucleus of modern medicine. However, during the pre-clinical development, the speed of delivery is necessitated over having an optimal synthetic route for producing the small quantities of APIs. Typically to address this while taking the project to the clinical development, an alternative synthetic route is required for producing Kg’s Level.
Once the API is approved by FDA, then an alternate commercial viable route is required for DMF filing. To address this need of phase-appropriate efforts to factorize fractious chemistry issues, Dr.Mark Laboratories performs route scouting and route comparison studies with a view to offer more efficient synthetic route(s) involving reduced number of process steps, cost viable process, less expensive raw materials, better safety aspects and so on.
Thereafter, the company plays a pivotal part in route optimization studies, impurity identification and synthesis and laboratory validations, followed by technology transfer, wherein Team Dr.Mark Laboratories identifies the most appropriate commercialization path keeping in consideration the stipulated delivery timelines and costs involved.
Thus Dr.Mark Laboratories creates a holistic integration strategy that blends the team’s process chemistry expertise together with analytical solutions that ideally suit your goals.
Pharmaceutical intermediates are primarily used as Raw materials or Key starting materials or Advanced intermediates during the manufacture of Active Pharmaceutical Ingredient (Bulk Drugs). However, the APIs need to undergo additional molecular processing or changes prior to their transformation into a final finished product (tablet, capsule, cream, ointment or injectable form). Dr.Mark Laboratories’ strengths lie in the ability to develop the most cost effective and commercially viable new routes to pharmaceutical intermediates. Toward this end, Team Dr.Mark Labs successfully takes the lab processes to the manufacturing plant and delivers required quantity of pharmaceutical intermediates as per desired specifications and within agreed delivery timelines.
Pharmaceutical impurities are the key aspects of a drug which produce an effect — they affect the purity of the material of interest viz. Raw materials, Key starting materials, Pharmaceutical intermediates, Active Pharmaceutical Ingredient (Drug substance) and drug product. Therefore, the specifications for a new drug substance and drug product must include tangible limits for impurities. Stability studies, chemical development studies, and routine batch analyses can be applied to predict those impurities which are likely to occur in the commercial product.
Dr.Mark Labs fully collaborates with client-companies in developing sought after therapeutic solutions. The company has required skill set and maintains the highest quality standards to work toward expediting the synthesis of any pharmaceutical impurities of drug substance and drug product, metabolites, degradants, by-products and so on.