As an independent provider of development and manufacturing services for pharmaceutical ingredients we have had more than 20 well-known German and international R&D pharmaceutical and generic enterprises as our clients since the establishment of our company in the year 2007. Hapila GmbH has been growing continuously. There are all in all 10 laboratories and 2 GMP multifunctional facilities on a 100 L scale available for physico-chemical and analytical operations.
List of References:
Description | Number
of Customers | | Number
of Projects | | Business
Unit |
|
- Preparation of difficult-to-make reference substances (APIs and impurities) incl. comprehensive analytical characterization, substance data-sheets and Certificate of Analysis (CoA) for customers
| >5 | | >20 | | Synthesis |
- Optimization of GMP-syntheses, performed at production scale in customer plants; tech-transfer of the results synthesis and analytics to customer manufacturing site
| 2 | | 4 | | Synthesis |
- Development of dedicated chemical steps including development of analytical methods for customers, tech-transfer to customer laboratory, incl. full documentation
| 1 | | 1 | | Synthesis |
- Comprehensive development of synthesis and analytical methods for multi-step processes (3…15 steps) for API-manufacturing, including Regulatory Affairs (CEP) and DMF/ASMF-Support for API-part 3.2.S
| 4 | | 4 | | Synthesis |
- GMP-Manufacturing of APIs incl. analytical release (CoA, CoC) according to the procedures for customers approved/licensed Drug Products, Batch-Size 1g – 100g – 1kg - 10kg
| 3 | | 3 | | Synthesis |
- Comprehensive development of multi-step synthesis incl. GMP-related documentation and subsequent tech-transfer of the process to customers manufacturing site (Pharma- or Generic company with own API-manufacturing)
| 1 | | 3 | | Synthesis |
- Development of Particle-Engineering processes (with technical co-operation partner), with subsequent GMP-manufacturing by HAPILA
| 2 | | 2 | | Particle Design |
- Optimization of crystallization processes for the purification of APIs, intermediates, dedicated fine chemicals, solar dyestuff
| 3 | | 3 | | Purification |
- Development of a semi-continuous counter current multi-step crystallization process (HAPIpur®-Technology)
| 1 | | 1 | | Purification |
- GMP certifications for API-manufacturing (issuing authority: Thuringia/Germany)
| 3 | | 3 | | Synthesis |
