Drug development and manufacturing organization
with a strong expertise in oncology
Drug development and manufacturing
organization with a strong
expertise in oncology
NerPharMa operates as a CDMO bringing highly potent compounds to the marketplace
NerPharma has brought new products and unique innovative technologies to the market over the years, delivering a wide range of GMP services through its agile and flexible facilities.
NerPharMa owns a wide and cutting edge organizational structure able to manage and handle highly active compounds, and to ensure the full development and production of active principles and finished products intended for the world market as well as the research and development of innovative formulation and delivery systems.
The two dvisions operate in accordance with Current Good Manufacturing Practices (cGMP) and are authorized by the most relevant authorities: Italian Drug Agency (AIFA), U.S. Food and Drug Administration (FDA), ANVISA Brasil, China FDA, PMDA Japan and Russia for the production of both pharmaceutical active ingredients and finished products.
NerPharma operates worldwide and with more than 30 customers
We have more than 15 products on the market and three unique innovative technologies approved in the last two years.
With our deeply and multidiscipilinary expertise we can support our customers in developing and implementing New Chemical Entities and innovative formulations from the scratch.
We support our customer in every step of the process by providing multiple services including
the production of the active ingredient and its formulation, packaging, clinical supply chain management, and obtaining regulatory approvals in the various countries.
NerPharMa operates since 2010 and our strong specialisation in oncology, our competence and experience make us able to optimise the entire development process till the launch of the product on the market.
From API to drug Product
Nerpharma has two separate divisions:
NerPharma DP (Drug Product)
can support the development and production of injectable products (solutions, suspensions and lyophilized products) and oral solid products (tablets and capsules) for different therapeutic areas, by handling Proteine Kinase Inibitors, cytotoxic and cytostatic products (not only oncological) and with formulation, packaging and distribution activities.
NerPharMa DP operates in accordance with Current Good Manufacturing Practices (CGMP) and is authorised to manufacture and package Medicinal Products issued by the Italian Regulatory Agency (AIFA).
NerPharMa DS (Drug Substance)
develops and manufactures exclusively product for oncology (Protein Kinase Inibitor, cytotoxic/cytostatic), from laboratory scale to commercial.
NerPharMa DS operates in accordance with Current Good Manufacturing Practices (CGMP) and is authorised to manufacture of high potent drug substances by the Italian Regulatory Agency (AIFA).
NerPharMa provides a fully integrated and multidisciplinary support to its customers in order to meet the project milestones on time and with high quality standards.
We take care of pharmaceutical forms development based on the active ingredient supplied by the customer or manufactured by NerPharma DS, following every phase of the process, from the laboratory to patient kits assembly, the industrialization phase up to the launch of the product on the market.
We guide complex compounds securely and efficiently from development through commercial manufacture.
We offer to our partners guidance and consulting in IMPD, IND, DMF, CMC and dossier preparation and filing.
We take care of packaging products used by hospitals for clinical studies. We combine patient kits, consisting of the primary and associated drug.
Thanks to our excellent analytical instrumentation, our laboratory is able to develop specific methods to certify and release any type of product on the market.