Active Pharmaceutical Ingredient (API) is the biologically active component of a drug product (tablet, capsule, cream, injectable) that produces the intended effects.
Impurity profile studies play significant roles in active pharmaceutical ingredient (API) development, which are closely related to the quality, safety and efficacy of drug products.
Contract manufacturing involves production of goods by firm, under the label of another firm.Contract manufacturers provide such service to several firms based on their own or consumers specifications.
The goal of scale-up is to identify & develop a process that will successfully produce a desired product when manufactured at a commercial scale.
the process by which manufacturers look for ways to improve their manufacturing process. A product's or system's optimization can take place on several levels.
Scaling up production to deliver more quantity of the product. Delivering with the same quality and efficiency.
We Regulatory give documentation of our products with Drug master file. DMF the set of series of information for an Active Pharmaceutical Ingredient (API) or Drug substance brought together in CTD format as per regulatory requirements.