Cambrex

FLAMMA is a CDMO with Headquarters near Milan, Italy. As a fully integrated CDMO, we can leverage our 100% self-owned, self-managed facilities, in Italy, China and the USA to deliver a stable, reliable supply chain.

We specialize in the cGMP manufacturing of:
• APIs
• NCEs
• RSMs
• Advanced intermediates (NCEs and generics).

We use our expertise in high value chiral materials (specifically amino acid related materials) to provide solutions to customers who not only have need for chiral materials but also clients who have other requirements with a various type of chemistries.

In addition, we also manufacture specialty compounds and advanced intermediates for the nutraceutical and cosmetic industries. Flamma also has a variety of niche generic products.

FLAMMA has four state of the art cGMP manufacturing facilities, each with its own R&D staff and labs.

Italy
1. Flamma Chignolo has 120 m3 capacity
2. Flamma Isso has 130 m3 capacity

China
3. Flamma Honkai is located outside of Dalian, China with 200 m3 of capacity
-> Flamma Honkai provides the security of constant Italian management
& oversight. It is like having an Italian facility in China.

USA
4. Flamma USA is located in Malvern, PA outside of Philadelphia
-> Flamma-delpia features a cGMP Pilot Plant, 6 standard cGMP kilo lab suites, 1 cGMP HPAPI kilo lab suite, 22 fume hoods, an analytical development lab as well as a QC lab, and additional space for future expansion for any necessary analytical, chemistry, and/or warehouse needs.

Flamma works on both early stage pre-clinical development of small molecules (multi-kilo) as well as large-scale commercial manufacturing (MT). With over 600 employees and a total capacity of 450 m3 and the flexibility to use three different manufacturing sites and four different R&D labs, see why Flamma is the “go to” contract manufacturer of the pharma industry. Experience the FLAMMA difference today!

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FLAMMA- The Thinking CDMO™
http://www.flammagroup.com

AcceleDev is a small molecule development & production company, with a staff of 100 people. Global operations include R&D & manufacturing sites in USA & China. Business specialties in the areas of "custom synthesis of advances intermediates"​ & "qualification/supply of raw materials"​, primarily in support of Pharmaceutical API programs.

Own products (APIs) for the generic pharmaceutical industry.

We provide quality products and services, consistently,
reliably responsibly and continuously applying some of the world’s
most difficult to handle chemical technologies.
Our independent one-site,
single entity corporate setup enables


Synthesis: Manufacturing services and products for all user industries,
using Archimica´s highly differentiated setup and technologies
APIs, Building blocks, GMP intermediates, Regulatory Starting Materials
For all global markets including the United States of America,
in total Archimica products reach 25 countries.

PREMIUM PHARMACEUTICAL INGREDIENTS - MANUFACTURED EXCLUSIVELY IN THE USA
BioSpectra is a US Based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buffers and Solutions. Our focus is small molecule synthesis and true, phase change multi-step purification for both traditional and bio-pharmaceutical applications. Our services include Contract GMP product development coupled with ongoing commercial manufacturing and regulatory support up to and including DMF submissions. All of our manufacturing processes are fully validated. Our US-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources.

Our commitment is to quality, compliance and true, US-GMP manufacturing, testing and regulatory support is unparalleled. We own and operate out of 175,000 square feet of FDA registered & inspected GMP manufacturing space, under the most rigorous quality system while holding to the most stringent regulatory demands. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have.

GMP Product Categories:
• Bulk, GMP Biological Buffers
• Active & functional Excipients
• GMP Process Chemicals and Bulk GMP Solution Solutions

Custom GMP Services Include:
• Purification of Key Ingredients
• Full GMP Product Development
• Small Molecule Custom Synthesis
• API Development & Manufacturing
• Custom GMP Compounded Solvents & Solutions

Comprehensive Quality and Regulatory Program
• FDA Registered and Inspected
• Document Support - DMF Submissions
• Global GMP Requirements – US, IPEC, ICH Q7

CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across Europe and the US organized under four technology platforms – Peptides, Lipids & Carbohydrates – Injectables - Highly Potent & Oncology - Small Molecules - CordenPharma experts translate complex ideas, processes and projects at any stage of development into high-value products.

<< Peptides, Lipids & Carbohydrates >>

• Synthetic Peptide API Production
- Solid-phase, Liquid-phase, Hybrid Synthesis
- cGMP & non-cGMP
• Synthetic Lipids
• Carbohydrates

<< Sterile Injectables >>

• New Development & Commercial Suites for Aseptic Filling with > 60.000 units
per day (Pre-filled Syringes, Liquid or Lyophilized Vials)
• Packaging, Labeling & Logistics
• Sterile Emulsion Technology
• Large Pre-Filled Syringes
• Clinical Trial Services

<< Highly Potent & Oncology >>

• API Development & Commercial Manufacturing
(SafeBridge Category 4, OEL ≤1 ng/m3)
- New Development & Scale-up Capacity for Phase I/II Supply
• Drug Product Development & Manufacturing
- New Development Suite (CTD2) for Mid-scale Oral Dosage (up to 20 kg)
- Sterile Liquid & Lyophilization
- Primary & Secondary Packaging

<< Small Molecules >>

• Development & Commercial Manufacturing
- Intermediates
- APIs & Excipients
- Clinical Supply Phases I-III
• Proprietary & Generic Advanced Intermediates & APIs

Visit > www.cordenpharma.com