CordenPharma

latina

EXPERTS TAKING CARE

Our History • 1969 Foundation • 1971 API penicillin production • 1975 API cephalosporin & Drug Product penicillin manufacturing • 1983 Drug Product oncology manufacturing • 1994 Drug Product cephalosporin manufacturing • 2004 New API oral penicillins • 2005 Fully integrated waste water treatment plant • 2010 Acquisition by ICIG to become CordenPharma Latina

us



cordenpharma

latina As one of CordenPharma’s multiple cGMP facilities across Europe and the US, CordenPharma Latina, located just south of Rome in Italy, is a fully-integrated manufacturer of oral & sterile anti-infective penicillin and cephalosporin

Full-Service CMO 40 Years of Experience

Drug Products, oral & sterile oncological formulation, and oral API molecule synthesis. Core capabilities include expertise in process development, process improvement and complex technology transfer as well as new product launches, industrial

engineering and scale-up in a full-scale multi-purpose facility. We serve over 70 markets worldwide with flexible solutions to support pharmaceutical API and Drug Product requirements for the rapid launch of new products.

Compliance Worldwide • EMA (AIFA) • FDA • ANVISA • PMDA • TGA • Health Canada

what we do

Sterile Oncology - Betalactams

CordenPharma Latina brings pharmaceutical customers over 40 years of experience in the efficient manufacturing of ß-lactam APIs and Drug Products, and over 30 years of experience in the expert production of oncology products (both parenteral & oral forms) and lyophilized formulations.

Core Capabilities

Other Specialties

• cGMP Manufacturing of cytotoxic oncology products in oral, liquid and lyophilized forms

Cordenpharma Latina is fully-integrated with management platforms including:

• cGMP Manufacturing of APIs and Drug Products for oral and sterile anti-infectives, such as cephalosporins and penicillins, in fully dedicated facilities

• Solvent recovery

• Proven expertise in development, technology transfer, scale-up, and launch

• Thermal oxidizer • Incinerator • Waste water treatment plant • Solid waste management

• Expertise in supplying products to the Japanese market • Extensive packaging and logistics services for the global market with customer service over 90% satisfaction • Fully-integrated infrastructure (solvent recovery, thermal oxidizer, waste water treatment plant)

Our experts manage over 500 SKUs and serve more than 70 markets with products from our diversified customer portfolio.

APIs

DRug PRODUCTS

• More then 400 m³ reactor capacity spread over a variety of stainless steel, glass-lined and hastelloy vessels with hot and cryogenic capabilities

• Pharmaceutical manufacturing in 3 independent buildings dedicated to cytotoxic, cephalosporins and penicillins in oral and sterile forms

• Multiple isolation and drying technologies

• API oral - 1000 MT

• Dedicated building for handling cytotoxic compounds: - Injectable solutions – 4M units/yr - Oral forms (tablets and capsules) – 300K units/yr respectively - Lyophilized formulations – exceeding 2M units/yr

• API sterile - 150 MT

• Cephalosporins & penicillins

• Dedicated production buildings for (oral and sterile) penicillin & cephalosporin manufacturing • Non-Beta lactams pilot plant and manufacturing plant

• Sterile powder filling on dedicated packaging lines – >30M units/yr • Manufacturing of tablets, capsules and oral suspensions on dedicated packaging lines – >10M units/yr of powder for oral suspensions, 1B units/yr for tablets and capsules respectively

Product & Technology Transfer CordenPharma Latina’s team of scientists support the transfer of drug products from research and development centers and other manufacturing sites with transfer experience that ranges from designing and building a dedicated line to stringent technology transfer in accordance with regulatory requirements. Our high level of transparency and communication of proposals and deliverables are key drivers for your seamless transfer success.

Optimized Global Supply Chain Managing a non-integrated supply chain delivers significant hidden costs linked to complexity management, inventory delays and transportation costs. CordenPharma and its global network of cGMP facilities work together with you to optimize your global supply chain with integrated supply solutions from the development of APIs to final packaging and commercialization. Our proprietary replenishment model is a service that significantly improves customer cash flow management, as well as overall customer service, without additional supply chain overhead. During launch and post launch, we maintain close proximity with your market planning functions to ensure continuity of supply, alignment of the supply chain and minimal inventory.

Our experience with rapid launch provides customers with Drug Products to distribution centers within days of their regulatory approval from agencies.

CordenPharma Latina Via del Murillo km 2,800 04013 Sermoneta Italy Phone +39 07 73 31 01 Fax +39 07 73 31 98 55 [email protected] www.cordenpharma.com