Competence for solid forms

Dragenopharm is a global contract manufacturer for solid forms in the pharmaceutical and the health care section with headquarters in Tittmoning. Additional locations are Berlin, Neuötting and Warstein. The innovative enterprise with highest pharmaceutical competence is a leading European guarantor concerning quality as regards to manufacturing and development of pharmaceutical products in full service.

For more than 50 years Dragenopharm Apotheker Püschl GmbH is a competent partner for development, contract manufacturing and packaging of granulates, hard gel capsules, tablets, film-coated tablets and sugar-coated tablets. With a lot of experience and knowledge the company brings innovative and justly top-quality pharmaceutical products to the market.

Since 2008 Dragenopharm Apotheker Püschl GmbH is prepared to offer an even more extensive range of laboratory services because of an enlarged new building in the headquarters. There, you literally can look over the shoulder of the highly qualified laboratory staff according to the company’s main business goal “transparency in all work steps“. Also in the future the Dragenopharm Apotheker Püschl GmbH always will be one step ahead as regards development and quality control!

History of more than 50 years experience and innovation
1949. Foundation of the Dragina, Traunreut
1953. Change of name into Dragenopharm Apotheker Püschl KG
1988/89. Production of first generic product and coated tablet
1992. Over-take of the production site in Warstein
1996. Movement of the office to Tittmoning and certification according to DIN ISO 9001/14001, eco-site
2001. Over-take of the production site in Berlin
2002/03. Awards: Bavarian Top 50 and European Best 500
2004. Construction of new production site in Neuötting
2007. New Investor Bridgepoint Capital Limited
2008. Heiko Bjarsch becomes CEO having been plant manager for a long time. Opening of the new laboratory and administration building in the headquarters in Tittmoning. Merger with Swiss Caps Holding AG into Aenova Holding. Certification according to DIN ISO 27001

Pharma-Full-Service
Being the leading contract manufacturer with specialisation to solid forms the company is a competent partner for the pharmaceutical industry. It offers extensive full-service for the development, production and packaging up to outbound logistics. The lead in technology, know-how especially in the growing section of coated tablets and sugar-coated tablets and the specialisation to development and production of Generics are characteristic features. Customers from all over the world trust in the high quality class of the products.

Qualified staff
For a constantly smooth flow from the inbound up to the outbound logistics, the Dragenopharm Apotheker Püschl GmbH  focuses on well-educated and continuously trained staff. Many employees work in the enterprise for many years and decades. Team spirit and individual responsibility are of crucial importance.

Solid mutual trust
Quality assurance plays a central role in pharmaceutical manufacturing. Minimum deviations might have direct consequences to the user’s health. Therefore, Dragenopharm Apotheker Püschl GmbH always is conscious of bearing a heavy responsibility. With ISO-certificates the company guarantees a complete quality management; naturally according to all GMP-guidelines as well as the EU-norm PIC.

The control mechanisms widely exceed the legally compulsory measures.

Future lies in environmental protection
Being a long-time member of the environmental pact Bavaria, the company focuses on a permanently environment-friendly growth. Reduction of current and future environmental pollution to a minimum, keeping the output of emissions as low as possible and concention on continuous energy and material management are Dragenopharm Apotheker Püschl GmbH’s targets.

Living transparency
Highest standard concerning safety, quality and environment is standardised in all production areas of all sites as well as in the newly built laboratory and administration building in site Tittmoning. In sum on 15.000 sqm.  the maximum possible transparency is provided.

Analytics with precision
Highly modern precision equipment as well as experience over decades in the section of physical and chemical analysis of active pharmaceutical ingredients, adjuvants and finished products is offered. In the framework of fully automated Content Uniformity and Dissolution testing environment the company checks all initial, intermediate and finished products.

New in the laboratory since 2008
EU-release laboratory for solid, half-solid, liquid and sterile pharmaceuticals from third countries

Imports in compliance with import certificate, tests of drugs and releases for the placing on the market according to AMWHV with the help of a qualified person

Further business activities

Examination and release
- of pharmaceutical active ingredients and adjuvants according to monography or own parameters
- for packaging or sales of solid oral forms from Dragenopharm Apotheker Püschl GmbH
contract manufacturing in compliance with authorisation documents
- for raw material out of production of third companies from all over the world under
application of GMP-certificates
- documentations of manufacturers and audits carried out by own QP-team
- development, qualification and validation of analytic test methods
- method transfer from laboratory to laboratory
- storage and examination of stabilities in compliance with ICH-guidelines
- GMP-audits of manufacturers of source material and finished products all over the  
world
- Analytic examinations:
Being a competent laboratory service provider the enterprise offers a widespread range of analytic examination by means of physical examination, titration, UV-VIS, HPLC, FTIR, NIR, GC, ICP and MS.

Flexible production
Tailored to market need, flexible and prompt− production has to be this way. With innovative development methods and state-of-the-art equipment nothing is left to be desired for the customers. Always one step ahead compared with the competitors by a continuous improvement of the whole processes!

Continuous control
Each production step is subject to a computer-aided monitoring without any gaps. This allows tracing from weighing to the finished product at any point of time. The control of the finished product is carried out under the application of state-of-the-art analytical techniques. They contain stability examinations by means of high performance liquid chromatography, gas chromatography and high-speed chromatography as well as UV photometry.

Granulation
Not all active pharmaceutical ingredients are suitable for direct pressing and therefore, we carefully add necessary adjuvants in our granulation. Only a few European contract manufacturers for solid forms dispose of a fluid bed granulator with solvent recovery like we do. Dragenopharm Apotheker Püschl GmbH can master a daily capacity of about ten (10) tonnes of granulate.

Capacities:
  •  moist granulation
  •  fliud bed spray granulation
  •  drying
  •  dry mixture
  •  compaction
  •  sieving machines

Tabletting
With more than twenty (20) high-speed tablet presses the enterprise provides a product capacity of about eight (8) billion pressings per year representing the preliminary stage for coated tablets and sugar-coated tablets. Also coated tablets and multilayer tablets can be counted to the performance range. State-of-the-art change heads are applied and the company disposes of identical tablet presses and a computer-aided administration of form sets. This leads to the ability to react extremely flexible to different production orders.

Coating
The nine (9) coating machines master up to three tonnes tablet material per day. They run computer-operated and they are connected to network documentation without any gaps. No step of production ends without documentation and control in the company. We dispose of explosion-proof rooms for handling and recovery of organic solvents.

Sugar-coating
Dragenopharm Apotheker Püschl GmbH disposes of more than fourty (40) coating pans for conventional sugar-coating with an overall capacity exceeding ten tonnes per process. Hereby, the company reaches the world’s highest capacity of the branch. Sugar-coated tablets in silver and gold are a particular speciality. Profit from more than 50 years of experience in this section!

Packaging
Dragenopharm Apotheker Püschl GmbH disposes using high-speed counting machines with an output of about ten thousand tablets per minute for the filling into each required form or size of glass or can. The customers also get powder fillings and fillings of granulate in bottles.
On a total of thirteen (13) lines for blisters the enterprise fully automated packages different materials like Aluminium against Aluminium or Aclar or PVC/PVDC or PVC/PE/PVDC.
Made-to-measure forms on demand can be requested. Also in the sections of cartons, package leaflets and labels Dragenopharm Apotheker Püschl GmbH implements the requirements. Product monitoring in the packaging department is carried out by means of barcode, video and post-process product testing and weighing.

Perfected logistics
You can use the voluminous capacity of the high rack warehouse as long as necessary for saving unnecessary intermediate ways. Dragenopharm Apotheker Püschl GmbH willingly delivers directly to the end user. With the shipping the product does not yet leave the quality control system. While all delivery documents are prepared, a last inspection is carried out by the head of Quality Control. Afterwards each pallet is packaged dust- and dirt-proof before it is released for transport.

Made-to-measure ERP-solutions for more security
The ERP-system ScarabaeusPLUS – implemented in cooperation with scarabaeusTEC GmbH – for the company has fully proven its value for about three years. All targets have been reached especially concerning the complete quality assurance and documentation in each production step. All units in Dragenopharm Apotheker Püschl GmbH are connected with the main computer and therefore, they are part of the control system without gaps. The whole process from the execution of inspection orders, the release of batches up to the printing of the certificate of analysis is completely supported by the system.

Some advantages of ScarabaeusPLUS:
  •  complete batch record and batch traceability of all manufacturing steps
  •  integrated computer-aided weighing-system for highest pharmaceutical drug safety
  •  pharmaceutical qualification of the solvent in compliance with EU-, GMP- and FDA-guidelines