The Active Pharmaceutical Ingredient (API) industry has witnessed steady growth in recent years and with a healthy balance between growing demand and supply, the numbers are only expected to go up. But with the large volume of business involved, and the fact that APIs are manufactured through a very complex process utilizing a range of processing technologies - chemical synthesis, extraction, cell culture/fermentation, gene therapy, use of blood or plasma as raw material, by recovery from natural sources, or by any combination of these, mean - the API manufacturers have quite a few challenges to deal with.
Adhering to strict safety and quality standards, set by both the country of production as well as end-consumption, controlling costs, addressing increasing pressure to reduce waste and manage the by-products efficiently, facing intense competition in the highly-fragmented market where patent expiry of branded products further results in expansion of generic sector, making the supply chain more transparent, et al are some of the issues that prove too difficult to handle for the API manufacturers. So whom do they turn to?
The solution is BatchMaster ERP for API, a customized ERP for the API manufacturers. Its powerful features allow them to produce high-quality and cost-effective products by providing complete control and visibility across the supply chain. Supporting all business models be it- own manufacturing contract manufacturing, loan-licensing or mixed, BatchMaster ERP for API supports all and to perfection through its specialized features.
BatchMaster ERP for API is designed to streamline all stages of API manufacturing be it chemical or bio-synthesis right from starting material, intermediates, their isolation & purification, to physical processing and packaging along with ensuring physical processing & packaging, purification and safe disposal of impurities to ensure efficient by-product management.
Compliance with industry-specific regulations of labeling, Bi-directional lot traceability, FDA 21 CFR part 11, adverse event reporting, accurate product costing, robust material and production planning, access to the real-time information et al are some other benefits API manufacturers enjoy with BatchMaster ERP for API.