Haupt Pharma Now Part of the Aenova Group for Product Development, Clinical Trial Supply Management and Commercial Manufacturing in FDA-Approved Facilities

Haupt Pharma

With a planned turnover of around €750m in the current financial year, the Aenova Group is one of the leading companies in the global pharmaceutical and healthcare industry.

The group’s portfolio of services covers the entire value chain for the development and production of all the main dosage forms and product groups in the field of medicines and dietary supplements.

The Aenova Group’s high standards of quality, innovative technologies and clear vision for the future have enabled it to become European market leader in the business-to-business field.

The company, which has its headquarters near Munich, operates 20 sites in seven countries throughout the world.

More than 4,000 employees contribute to the group’s success.

Haupt Pharma is one of the largest European companies for pharmaceutical contract development and manufacturing, with nine sites in Italy, Japan, France and Germany, as well as an office in the US.

The company provides outsourcing services for more than 200 pharmaceutical clients, which includes the production of pharmaceuticals, cosmetics, dietary supplements, speciality products and veterinary medicine.

With the full service ranging from pharmaceutical development, materials procurement, production and packaging, to logistics and distribution, Haupt Pharma offer customized solutions for almost all dosage forms.

As well as processing conventional APIs, the company develops and produces speciality products, including:

  • Cytotoxics
  • Hormones
  • Beta-lactam antibiotics (penicillins / cephalosporins)
  • Narcotics

Pharmaceutical development and commercial production

Haupt Pharma’s development service is available for almost any pharmaceutical market. The service, which is used by many multinational companies, covers the entire process chain, starting at pharmaceutical development and covering everything including scale-up and commercial production. Features of Haupt Pharma’s development service include:

  • Compliance with GMP standards and FDA-accredited areas
  • Complete analytical service, including microbiology
  • Scale-up optimised for time and cost, with transfer to production

The company’s development staff has expertise in a broad range of conventional pharmaceutical forms, as well as in lyophilizates. Products developed by Haupt Pharma include cytostatics, narcotics and hormones.

Supplies for Phase I to IV clinical trials

Haupt Pharma offers a broad range of services related to the management of clinical trial supplies.
A portfolio of standard pharmaceutical dosage forms is rounded off by lyophilized formulations.
In addition to conventional APIs, Haupt Phama handles cytostatics, hormones and controlled drugs.

Our customers benefit from:

  • Creative technical solutions for the realisation of complex study designs
  • Smallest batches for Phase I with efficient scale-up to Phase II/III for international, multi-center studies
  • Cold chain logistics and authorised depot for controlled drugs

Blinding / secondary packaging

  • Smart blinding concepts
  • Dose regime-specific secondary packaging
  • Special blister lines, also with modular format tools (Multiphase blisters, wallets, aluminum / aluminum blisters)
  • Patient kits
  • Bottles
  • Procurement and re-packaging of comparator drug products

Labeling

  • Multilingual labeling
  • In-house label printing
  • Booklet procurement and labeling
  • Printing of code breaks

Logistics

  • Overnight shipping of investigational drugs
  • Worldwide export including cold chain logistics
  • Import of investigational drugs, comparator medication and narcotics (including from the US)

Pharmaceutical contract manufacturing services

Haupt Pharma’s nine sites each provide specialist manufacturing of a specific dosage form or API group, enabling the company to provide expert contract manufacturing. Every site maintains GMP standards, and the majority are operated to fulfil US FDA and Japanese regulatory authority requirements.

The company’s Japanese site also provides a visual inpection service for bulk drugs from Europe and the US, and will package them for the Japanese market, a service that extends to products requiring cold chain storage.

Dosage forms that Haupt Pharma manufactures include:

Parenterals

  • Vials and ampoules (aseptically filled or terminally sterilised)
  • Lyophilizates

Solids

  • Tablets, film-coated tablets
  • Sugar-coated tablets
  • Hard capsules
  • Dry syrups
  • Granulates, powder

Liquids and semi-solids

  • Oral, nasal and other solutions
  • Emulsions, suspensions
  • Gels, creams, ointments
  • Suppositories

Haupt Pharma’s areas of special expertise:

  • Oral: cytotoxics, penicillins, sex hormones, thyroid hormones, highly colouring substances (such as sulfasalazine), corticosteroids
  • Parenteral: cytotoxics, penicillins, cephaloporins, corticosteroids
  • Veterinary: penicillins / cephaloporins for mastitis treatment in cows

Product quality and employee safety are top priorities at Haupt Pharma. With completely separated production areas for highly potent substances, the company assumes a leading position in this area. Haupt Pharma has dedicated areas for the production of oral thyroid and sex hormones and meets the safety requirements for narcotics and cytotoxics.

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Press Release

Haupt Pharma Passes FDA Inspection at Haupt Pharma Amareg

Haupt Pharma, one of Europe's leading contract developers and manufacturers, has successfully passed an inspection by the US Food and Drug Administration (FDA) at its site in Regensburg, Germany, without any FDA-483 observation being issued. Haupt Pharma Amareg has extensive know-how i

White Papers

Haupt Pharma: Veterinary Competence

Haupt Pharma is one of the leading contract developers and manufacturers for pharmaceutical products in Europe.

Address
HAUPT Pharma AG

Pfaffenriederstr. 5-7

82515 Wolfratshausen

Other

Germany

+49 (8171) 414 126 +49 (8171) 414 109 www.haupt-pharma.com

Haupt Pharma Images

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Press Release

26 November 2013

Haupt Pharma has successfully passed an inspection by the US Food and Drug Administration (FDA) at its site in Regensburg, Germany.

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31 October 2013

The Aenova Group is continuing its successful period of growth, recently announcing a merger with Haupt Pharma that will help it achieve a strategic expansion of its portfolio.

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24 October 2013

The Aenova Group, one of the leading companies in the pharmaceutical and healthcare industry, is continuing its successful period of growth.

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3 September 2013

Haupt Pharma is pleased to announce that it will exhibit at the CPhI Worldwide 2013. With nine sites in Germany, Italy, France and Japan, and a representative office in the US, Haupt Pharma is one of the largest European companies for pharmaceutical contract development and manufacturing.

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28 August 2013

Haupt Pharma Amareg GmbH, a part of one of Europe's leading companies for pharmaceutical contract development and manufacturing, celebrates its 10th anniversary today with a grand ceremony at the company's premises. The site has a long tradition and a solid performance in the manufacturing pharmaceuticals and expects further expansion of production and personnel in the future.

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20 August 2013

Haupt Pharma, one of Europe's leading companies for pharmaceutical contract development and manufacturing, has completed the transfer of contraceptive pill production for a large group from Ireland to the Westphalian city of Münster. All of the equipment used to produce the contraceptives is already located in the facilities of Haupt Pharma Münster GmbH so that manufacturing can start immediately.

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16 October 2012

Haupt Pharma's site in Latina, Italy, Haupt Pharma Latina, is your expert for veterinary business. With over 20 years experience in aseptic manufactuiring and filling of suspensions into intramammary syringes and bottles, we offer a unique capability to customers operating the veterinary business.

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13 September 2012

Haupt Pharma, one of the leading European companies for pharmaceutical contract development and manufacturing, has successfully passed inspections by the US Food and Drug Administration (FDA) at four sites in Germany during the first half of 2012.

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29 February 2012

Haupt Pharma, one of Europe's leading pharmaceutical contract development and manufacturing organisations, has initiated a comprehensive project to optimise its supply chain.

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5 December 2011

Haupt Pharma, one of Europe's leading pharmaceutical companies for contract development and contract manufacturing, installed its new tablet press, Fette 1200i, at the Regensburg site in August 2011

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7 June 2011

Haupt Pharma, one of Europe's leading contract developers and manufacturers, has successfully passed an inspection by the US Food and Drug Administration (FDA) at its site in Regensburg, Germany, without any FDA-483 observation being issued. Haupt Pharma Amareg has extensive know-how i

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22 March 2011

Haupt Pharma, one of the largest pharmaceutical contract manufacturers and developers in Europe, now also fulfils the high demands of the International Food Standard (IFS). During the certification procedure at the end of January 2011 the Brackenheim site was awarded 98 out of a possible 100 poin

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7 November 2010

Haupt Pharma, one of the largest pharmaceutical contract manufacturers and developers in Europe, has commissioned new equipment for filling and packing liquids at its Wolfratshausen site. Now, with a total of two new production lines in the liquids division, Haupt Pharma is able to double its tot

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7 September 2010

Haupt Pharma Amareg has put a new Uhlmann blister line into operation for packaging cytostatics and immunosuppressives. This line allows the packaging of tablets or capsules in PVC/PVDC aluminium or alternatively in aluminium / aluminium blisters. The blister packing on the Uhlmann B

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7 September 2010

At the international trade fair for pharmaceutical outsourcing, the International Contract Services Expo (ICSE) in Paris from 5-7 October, the Haupt Pharma Group, one of the largest pharmaceutical contract manufacturers and developers in Europe, presents its extensive portfolio of services at sta

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27 June 2010

In April 2010, Haupt Pharma Amareg inaugurated several new purpose-built laboratories for pharmaceutical development, and in so doing increased its capacity for analytical development projects. These new laboratories are designed specifically to optimise the workflow of development task

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27 September 2009

Handling of sex hormones as highly potent, pharmacologically active substances requires increasingly complex facilities and machinery to protect the product, the workforce and the environment. Haupt Pharma meets these demands by continuously investing in modern technologies. The provided services

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22 September 2009

Due to increasing pressure regarding cost and complexity, many pharmaceutical companies prefer to collaborate only with a few contract manufacturers and bundle their activities with a strong full service provider. With nine different production sites, Haupt Pharma is one of Europe's lar

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23 June 2009

The requirements for quality and efficiency in the manufacturing of sterile products are steadily becoming more stringent. Haupt Pharma meets these demands by continuously investing in modern technologies. The performance of Haupt Pharma has been optimised further by a new filling system from Ino

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2 June 2009

High performance and efficiency are important aspects for a successful collaboration in contract manufacturing. To continue to be a competent contact partner for our customers in the future, Haupt Pharma Brackenheim has added an ultra-modern packaging line from Uhlmann to its equipment

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3 February 2009

Haupt Pharma, one of the world's largest pharmaceutical contract manufacturers and developers, announced today that it has completed the purchase of a Pfizer production site in Latina, Italy. With this asset deal, Haupt Pharma gets access to a plant focused on the production of antibiotics –

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30 September 2008

Mr Norbert Schwella has been appointed as the chief financial officer (CFO) and a member of the extended executive board of Haupt Pharma. The function of the CFO was created with regard to the increasing tasks and responsibilities to be handled with the integration of AMAREG and Wülfin

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31 August 2008

On 1 September 2008, the previously announced consolidation of the pharmaceutical contract manufacturers and developers AMAREG, Wülfing Pharma and Haupt Pharma, comes into force. This will create the most powerful company in its sector in Europe, with around 1500 employees and a turnover of €180

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31 July 2008

Please visit Haupt Pharma at the CPhI Worldwide 2008. You will find us in hall 4.2 at booth number 42 J 17. Venue: Messe Frankfurt, Germany Date: 30 September – 2 October Please pre-arrange for a meeting. ICSE and P-MEC will run alongside CPhI

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4 June 2008

Invita AG, an investment company that focuses on the pharmaceutical sector, is to merge its portfolio companies Amareg, Haupt Pharma and Wülfing Pharma as of September 1, 2008. The merger of these pharmaceutical contract manufacturers and developers will result in the most efficient company in it

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23 January 2008

Haupt Pharma Livron have received an accreditation certificate from Japan's Ministry of Health, Labour and Welfare. With this the company has been given the go-ahead as foreign contract manufacturer for the Japanese pharmaceutical market.

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22 January 2008

Haupt Pharma expands its production line for high potent drugs. By engaging in a cooperation with Siegfried Generics Malta the company is now also active on Malta and will extend its expertise there to specialization on the production of high potent APIs and hormones. The production site on Malta

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7 August 2007

With effect from April 1, 2007 the supervisory board has appointed Mr Werner Buerk to the management board of Haupt Pharma AG. The main focus of his new responsibility will be sales, marketing, and development. Mr Semmler remains CEO. Mr Buerk has studied biology in Hohenheim and has g

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7 August 2007

Haupt Pharma Business Development GmbH has shifted its company headquarters from Berlin to the Haupt Pharma site in Wolfratshausen. At the same time with the new financial year 2007 the company is renamed in Haupt Pharma Development GmbH. The expansion of development services throughout

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7 August 2007

Along with the start of his function in the management board, the new sales organisation Mr Buerk has set up will come into operation. The sales staff are now centrally managed and employed by Haupt Pharma AG and thus be able to perform their sales tasks across all sites. The central sa

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7 August 2007

The pharmaceutical contract manufacturer Haupt Pharma AG is preparing for IPO. The IPO should take place at the beginning of 2008 or 2009. Until then the company, which is mainly in private equity ownership wants to expand its international business.

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15 December 2006

Boehringer Ingelheim Seiyaku (Headquarters: Higashine-shi, Yamagata, president: Dr Gerhard Gigl) and Haupt Pharma announced today, that Boehringer Ingelheim Seiyaku, Nippon Boehringer Ingelheim's 100% subsidiary company, would de-merge and divest its Toride plant to Haupt Pharma, one of the leadi

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Regional Offices

HAUPT Pharma AG

Pfaffenriederstr. 5-7

82515 Wolfratshausen

Other

Germany

Hans-Wolfram Hardtke - Vice President Business Development +49 (8171) 414 126 +49 (8171) 414 109 www.haupt-pharma.com

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