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  • 2011/62/EU

    Also outside the line production

2011/62/EU

Also outside the line production

In 2011, the EU Falsified Medicines Directive (FMD) 2011/62/EU was published. It applies to all prescription-only and selected OTC drugs in the European Union.

Drug safety is a valuable asset that is repeatedly endangered by falsified drugs. According to an estimate by the US FDA (Food and Drug Administration), more than 10% of all drugs in circulation are believed to be counterfeit. A Community code has therefore been established at EU-level to prevent the entry of falsified medicinal products into the legal supply chain.

The implementation of the Directive concerns not only pharmaceuticals which are produced and packed on large production line but also small batches. In most cases, it is not cost effective to change the production line frequently.

With the udaFORMAXX, Koenig & Bauer offers a sophisticated solution.

Solupharm Pharmazeutische Erzeugnisse GmbH, based in Melsungen in Germany, also relies on this offline solution.

Millions of glass ampoules and glass phials

Solupharm is a modern and efficient familiy-owned company with state-of-the-art production facilities. The company is a strong and reliable partner for national and international customers. Every year,
millions of glass ampoules and glass phials are filled, inspected and packaged.

„Koenig & Bauer Coding, a longterm partner for coding systems, is the first point of contact for Solupharm.“

Kai Theer,
Teamleader Technical Services Packaging

01 2011/62/EU

With the udaFORMAXX with its own stack-to-stack processing, Solupharm GmbH separates flat folding cartons – even crash lock cartons, complex formats and insertable flaps – which must be identified with a serialised, unique code in accordance with Directive 2011/62/EU.

Each individual pack must be marked with the following information:
- Product identification number, in the format GTIN, NTIN (or PPN for Germany)
- Batch number
- Use by date
- Individual serial number of the single pack
- If necessary, national healthcare reimbursement numbers, NHRN, for reimbursement by national healthcare insurers


02 Track & Trace

Equipped with a DOD inkjet for coding and an inspection system with corresponding Track & Trace software, the udaFORMAXX offers a cost-effective solution that enables separation, serialisation and aggregation in the smallest place.

Every printed code is verified with a camera system and recorded in the database.

Folding cartons whose codes were rated as „bad“ during camera scanning are automatically rejected via the udaFORMAXX reject station and subsequently booked out of the database by software.


03 Solupharm GmbH

For more than 40 years, the name Solupharm has been synonymous with high-quality, responsible contract manufacturing of sterile preparations in glass ampoules and glass phials. The new building in Melsungen is one of the most modern production facilities in Germany.

Solupharm operates in a market where the highest standards of manufacturing processes and quality standards are essential.

The uda concept has been convincing us. The combination of systems from two machine builders in this compact solution is well thought-out and well implemented. In addition, the ergonomic operation of our systemis of course a highlight for the operator.

Kai Theer,
Teamleader Technical Services Packaging

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Silvia Stückler

Koenig & Bauer Coding GmbH
PLZ Bereich: 70, 71, 72, 73, 75, 76, 77, 78, 79, 88, 89


M: 0160 / 7198 724

E-Mail

Gunther Heilmann

Koenig & Bauer Coding GmbH
PLZ Bereich: 01, 02, 03, 04, 06, 08, 09, 10, 11, 12, 13, 14, 15, 16, 39

T: 034296 / 746983
M: 00160 / 90589443
F: 034296 / 746985

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Tim Kohl

Koenig & Bauer Coding GmbH
PLZ Bereich: 17, 18, 19, 20, 21, 22, 23, 24, 25


M: 0175 / 5826410
F: 04307 / 825330

E-Mail

Werner Rüdiger

Koenig & Bauer Coding GmbH
PLZ Bereich: 29, 30, 31, 38

T: 05131 / 467940
M: 0171 / 9717791
F: 05131 / 467941

E-Mail

Marcus Bauer

Koenig & Bauer Coding GmbH
PLZ Bereich: 07, 34, 35, 36, 37, 57, 99


M: 0160 / 90581022
F: 0931 / 9085101

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Heinrich Nierhoff

Koenig & Bauer Coding GmbH
PLZ Bereich: 32, 33, 44, 45, 46, 48, 49, 58, 59

T: 02377 / 809670
M: 0170 / 2207995
F: 02377 / 809671

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Alexi Towfighian

Koenig & Bauer Coding GmbH
PLZ Bereich: 40, 41, 42, 47, 50, 51

T: 02941 / 2709309
M: 0170 / 7625493
F: 02941 / 2867738

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Gunther Thummerer

Koenig & Bauer Coding GmbH
PLZ Bereich: 80, 81, 82, 83, 84, 85, 86, 87, 93, 94, 95, 96, 97, 98

T: 0971 / 7854566
M: 0151 / 14272648
F: 0971 / 7854577

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Simone Ankenbauer

Koenig & Bauer Coding GmbH
PLZ Bereich: 74, 90, 91, 92

T: 0174 / 7842117

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Koenig & Bauer Coding (FRA) SAS


142 chemin des égantiers ZAC de la Ronze
69440 Taluyers

T: +33 9 80 77 76 10
M: +33 6 64 51 45 79

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KBA-Metronic (Hangzhou) Co., Ltd


F9, North Building 10, No.88 Jiangling Rd, Binjiang District
310052 Hangzhou

T: 0086-571-87710500/520/530
F: 0086-571-87710535

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Koenig & Bauer Coding (NL) B.V.


Coenecoop 3B1
2741 PG Waddinxveen

T: +31 (0)10 522 60 52
F: +31 (0)10 522 40 29

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KBA-Metronic Polska Sp z.o.o.


Bukowska 17a
62-070 Dąbrowa /Poznań

T: 61 670 40 20
F: 61 670 40 20

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Koenig & Bauer Coding GmbH


Benzstraße 11
97209 Veitshöchheim

T: +49 (931) 9085 - 0
F: +49 (931) 9085 - 100

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Jennifer Peil

Koenig & Bauer Coding GmbH
PLZ Bereich: 52, 53


M: 0172 / 3133719

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Carsten Weßling

Koenig & Bauer Coding GmbH
PLZ Bereich: 26, 27, 28


M: 0172 / 3134023

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Frank Bindewald

Koenig & Bauer Coding GmbH
PLZ Bereich: 54, 55, 56, 60, 61, 63, 64, 65, 66, 67, 68, 69


M: 0171 / 9717790

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