Elite Pharmaceuticals, Inc.

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.

Drug Discovery Alliances is a provider of chemistry and formulation services bringing together scientific expertise and support during all stages of the R&D continuum for emerging biotechs, existing multinationals and the United States government. We provide a global service where our partners – located in N. America, China, Japan, Czech Republic, England, Germany and Italy – cover four key services:

Consulting
• CMC Project Management
• GMP Auditing
• Licensing
• Sourcing & Procurement

Drug Discovery
• Medicinal Chemistry

R&D/Pre-Clinical
• Analytical Method Development
• Catalysis Screening
• Crystallization
• Metabolites, Impurities ID & Synthesis
• Process Research
• Reference Standards
• Solid Form Capabilities

Manufacturing (Phase I-III)
• Advanced Intermediate Manufacturing
• API & Commercial Manufacturing
• cGMP Manufacturing
• Final Drug Product Manufacturing
• Formulation Development
• Quality and Regulatory Support
• Raw Material Manufacturing

Chemistry Technology Platforms
Aseptic Fill & Finish
• Chlorination
• Chromatography
• Cryogenic
• Distillation
• Fermentation
• Heck Reactions
• HPAPI / High Potency
• High Pressure
• High Temperature
• High Throughput / High Resolution X-ray Diffraction
• Hydrogenation
• Lyophilization
• Nitration
• Pastillation
• Phosgenation
• Polymorph Screening
• Powder Filling
• X-ray Crystallography

Project Examples
• 4 year program for development of Regulatory Starting Material supporting NDA filing for a neurology product
• Urgent API consulting for Clinical Phase III with supplier change and identified savings of $10M
• CMC project consulting on pre-IND candidates ($760M) for a CNS product licensed by Astellas
• Generic new formulation consulting supporting Clinical Phase III for 505(b)(2) for hypertension product
• Commercial API manufacture for ophthalmology product sourcing key suppliers leading to successful FDA approval
• Phase III API for antibody conjugate for oncology identifying key supplier

Who are we?
Efarmes is a generic pharmaceutical company devoted to develop and manufacture generics for third parties all over the world. Efarmes Generics Company is part of Lacer Group. Our head offices, manufacturing site with EU cGMP’s and R&D area are in Barcelona.

What we do?
Efarmes Generics Company seeks partners that want to in-license and market the generics. Our partners are both multinational and local pharmaceutical companies on the five continents. Efarmes Generics Company offers tailored-made proposals such as full development and manufacturing of generic pharmaceutical products ready to be marketed by third parties under their own brand name, co-development of generic products, and contract manufacturing.

How we do it?
Efarmes Generics Company covers all levels from formulation to finished product delivery. Efarmes Generics Company currently supplies finished dosage forms to many key players all over the world. Our manufacturing site plant produced last year 24 M units (3.240 batches) with 99,9% Quality Control Conforming.

Our Business Proposal
Our main business model is the out license and supply of generic finished dosage forms. Our dossiers are in EU CTD format and ready to file. We have some MAs available in Europe.

Dossiers ready to file:
- Rasagiline (Parkinson’s diseases)
- Alprazolam (Anxiolytic)
- Deflazacort (Corticosteroid)
- Modafinil (Narcolepsy)
- Sildenafil (Erectil Dysfunction)
- Pioglitazone (Diabetes)
- Rivastigmine (Alzheimer diseases)

Dossiers under development:
- Olmersartan + Amlodipine + Hidroclorothiazide (Hypertension). Q2 2016 Bioequivalence studies on-going.
- Tapentadol, retard tabs, (Neurophatic Pain). Dossier will be available in 2018.

Products which are subject to patent are currently not offered or made available in countries where patents are in force. No orders or deliveries prior to the expiry date of valid patents are possible.

Please, contact us on generics@efarmes.es

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!

Follow Us!

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

Hovione is an international company with +60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product.

With four FDA inspected sites in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and cGMP-compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.

“We do well what is difficult, to give our customers what they cannot find elsewhere.”