Contract Development and Manufacturing Organization

Contract Development and Contract Manufacturing Solutions at best 

Alfa is committed to serve the pharmaceutical industry across value chain with its well-crafted solutions for contract manufacturing and formulation development. Our emphasis has been to demonstrate what additional value our services can offer or if they can address any unmet needs. We constantly strive for innovative solutions, be it in terms of manufacturing or offering differentiated products.

Formulation Development

  • Alfa offers comprehensive and end to end solution to your needs including the
  • Formulation development,
  • Analytical method development and validation,
  • ICH Stability study and testing,
  • Clinical or BE studies,
  • Submission batches to commercial  production along with
  • Regulatory support from submission till the life cycle.
  • Technology Transfer, either our products for commercial manufacturing at partner’s site or transfer of customer’s technology to our manufacturing site for commercial supplies. Our technology team assists with the transfer and troubleshooting.

Committed to providing an end-to-end solution

Dose Form Exprtise

Tablet
Technologies Dosage Form Types

•       Matrix System

•       Osmotic System

•       Multi-unit particulate system

•       Drug layering

•       Solid dispersion

•       Film/Sugar coated

•       Modified release

•       Oral Disintegrating

•       Effervescent

•       Chewable

•       Sublingual / Buccal

•       Multi-layered

Capsule
Technologies Dosage Form Types

•       Powder in a capsule

•       Pellets in Capsule

•       Mini Tablets in capsules

•       Liquid in capsule

•       Hard gelatine capsules

•       Soft gelatine capsules

Liquids
Technologies Dosage Form Types

•       Powder in a capsule

•       Pellets in Capsule

•       Mini Tablets in capsules

•       Liquid in capsule

•       Hard gelatine capsules

•       Soft gelatine capsules

Powders
Technologies Dosage Form Types

•      Taste masking

•     Sugar free formulations

•      Flow and solubility enhancement

•      Sachets

•      Stick packs

Contract Manufacturing

With our partner’s EU GMP accredited production facilities, Alfa offers a broad range of dosage forms for Pharmaceutical and Consumer Health products. These manufacturing facilities are equipped with the latest production technologies and have proven expertise to support your product needs with the highest quality and reliability standards.

Dosage forms that could be manufactured:

  • Oral solids
  • Pellets
  • Sachets
  • Semi-solids
  • Sterile dosage forms
  • Soft gelatin capsules
  • Lozenges

Specialized capabilities:

  • Cytotoxics
  • Beta-lactams (Cephalosporins, Penicillins and Carbapenems)
  • Hormones and Corticosteroids
  • High potent compounds
Flexible Solutions

 1. Pilot batch Manufacturing

2. Scale up and Validations

3. Technology Transfers

Infrastructure

 Together with our partner’s, we offer manufacturing in four major segments:

  • General Oral Formulations –  Our EU-GMP approved facility is capable of manufacturing all types of Tablets, Pellets, Capsules and Dry Powders. Our facility houses all required equipment such as wet and dry granulation, FBP, Roll compaction etc to support majority of dosage forms. All types of primary packing like Alu-PVC/PVDC blisters. Alu-Alu, blisters. Strip, Bottles, Sachets etc as possible formulations.
  • β-Lactam Formulations – Dedicated and EU-GMP approved facility for manufacturing penicillin formulations in Tablets, Capsules and Dry power for solution.
  • Oncology Facility – Offering manufacturing for oral solid and injectable dosage forms. This recently commissioned facility is accredited with EU-GMP and is capable of managing any scale of program with best efficiency.
  • Oral Lozenges – Equipped with the best of equipment from Bosch and accredited with EU-GMP, TGA and many more, this site can manufacture sugar based or sugar free medicated as well as herbal lozenges.

Research Facilities

Alfa works with partner who has well-equipped and certified research facilities with a pool of scientists having technical expertise and experience to deliver in all aspects of pharmaceutical development process. Various teams can support seamlessly and efficiently each program with innovative and flexible solutions to make your drug product suitable for global markets.

Furthermore, our dedication to service also ensures that we deliver a cost effective yet quality product on time. Our focus remains on offering challenging and value-added solutions with the help of NDDS, platform technologies and innovative solutions.

Alfa’s and it’s partner’s core strength is formulation development, and we collaborate with pharmaceutical companies globally to either develop formulations specific to their needs or licensing of our developed products with supply of finished formulation.

Alfa Pharma GmbH
Donnersbergstrasse 4
64646 Heppenheim, Germany
Tel: +49 6252 9428 150
Fax: +49 6252 9428 151
Email: info@alfapharma.eu