We have worked with partner companies for over 20 years, providing contract manufacturing with back integrated sourcing on an exclusive basis. Our Nanjing office in China comprises full time chemically trained professionals who are responsible for project development and raw materials facility auditing (we have a qualified auditor trained to GMP).
We also offer a highly successful service of re-sourcing products (where there are regulatory question marks) to approved facilities saving our clients the cost of audits and providing a robust regulatory assured supply chain. This is achieved by having people on the ground who have superb networks, as well as current and constantly updated regulatory know how.
Please find a summary below of the capabilities that we can offer our clients in terms of contract manufacture. This is not an exhaustive list and each of our partners have special and unique attributes for which they were chosen. All sites have been audited and approved by multiple customers. We welcome our customers to visit and audit these facilities.
Capabilities of the partner facilities:
- All are FDA approved – no 483s
- Available capacity for projects
- Price competitive, we operate to EU standards but with a superior cost model
- Project management ability from conception to conclusion
- HACCP and FAMI-QS Registration in the EU
- GB/T28001:2001 (ISO18001)
- Internal evaluations
A Snapshot of Capacity at one site:
- Total area of current facility: 430,000 sq.ft.
- Total volume: 210,000L
- Number of workshops: 9
- Utilities: Steam (8 atm), Power (1000 Kva), Waste treatment facility (200MT/day)
- Volume of reactors: 50L-5000L
- Glass-lined reactors: 127. Stainless steel reactors: 12
- Temperature: -70℃ to 200 ℃
- Vacuum distillation equipment: 1.5mmHg
- High pressure: 50 atmosphere
Our success is built upon openness and consistency in all of our relationships, causing our clients to use us again and again. We would be pleased to welcome you to any of our facilities, please contact us to discuss further.
Alfa are frequently chosen as the partner of choice within the Pharma industry for the outsourcing of supply chain. Due to our superior knowledge of a large numbers of suppliers (and long standing relationships with them), coupled with technical expertise and regulatory know-how, we can take on the products that often occupy the time of procurement but are infrequent and occasional purchases. This gives two benefits to the client; firstly it allows them to have full traceability but one point on invoicing and contact, thus allowing a reduced burden on planners. Secondly, it allows the client to streamline their own logistics and auditing team, as Alfa can consolidate from an audit perspective, placing a large number of products in chosen facilities that meet all the regulatory requirements, thus save the client high volume audit requirements.
Our Global Transport partners have key relationships with the required authorities which allows us to offer a superior service from Asia. We have logistics experts coordinating stock moving all over the world from Asia and Europe. Our specialists maintain an up to date knowledge of regulatory requirements across the Pharma industry, including Falsified Medicines requirements and REACh. We aim to stay ahead of all new regulation across the world so that we can provide our customers with a fully reassured service. Please contact us for more details.
The pharmaceutical industry is a highly regulated market which is constantly evolving. Our staff are fully familiar with regulations concerning GMP, the Falsified Medicines Directive, and REACh FDA compliance, amongst others. We take a pro-active approach to ensuring that new regulatory knowledge is assimilated in to our activities. Please contact us for more details.