ALTAN BERNEDO

History

Altan Bernedo is a pharmaceutical plant located in the heart of Montaña Alavesa, in the Industrial Polygon of the town of Bernedo. It is located 42km away Vitoria and about 25 km from Logroño, surrounded by an enviable natural environment. France’s southwestern border is just 180 km away.

BIOMENDI S.A.U was founded in 1991 with public capital from several local entities. On February 2004 the company it’s acquired by Spain Pharma group becoming part of a Group of Companies (G.E.S. Genéricos Españoles y GENFARMA) dedicated exclusively to the fabrication and commercialization of medicines in the hospital sector.

Since mid-June 2015, BIOMENDI S.A.U., together with the rest of the group’s companies, belongs to the ALTAN Group.

On 1 January 2019, in the framework of an integration of the group of companies to which BIOMENDI S.A.U. belongs, the company has been part of an absorption merger operation, it has been absorbed by its parent company and shareholder Altan Pharmaceuticals, S.A.U. (previously denominated GES Genéricos Españoles Laboratorio, S.A.U.) (“Altan”).

Facilities and certifications

The plant has over 4000 m2 built, dedicated exclusively to the manufacture of its own specialities and to the manufacture to third parties of sterile medicines and sanitary products that are conditioned in flexible bags, whether PVC or PVC free.

Additionally it has 500 m2 dedicated to research and development activities.

Altan Bernedo develops a quality security system based on the Correct Manufacturing Standards, also certified according to ISO: 9001:2008 and ISO13485:2003.

It also has the CE marking for Sanitary Products according to Royal Decree 93/42/EEC.

The laboratory has three independent manufacturing lines with terminal sterilization with a capacity of about 15 million units per year.

The facilities are based on the concept of flexibility, allowing the manufacture of bags from 40 ml to 3000 ml. The design of the facilities allows the manufacture of short and medium run products, with flexible industrial scales.

The plant is designated by the concept of Linear Product Flow, trying to avoid product or crossover recoil movements. Thanks to this, the Raw Materials Warehouse is close to the sampling, dispensing and preparation area of solutions. Also, the Final Product Warehouse is close to the end of the different lines like the Final Packaging and the Finished Product Warehouse.

Employees

The company has more than 150 employees. Close to the 20% of the workers contain a Bachelor’s degree, especially focused on Health Sciences, such as Chemistry, Pharmacy and Biology.

Altan Bernedo provides initial and periodic training for all its employees.

Developed activities

Altan Bernedo is autorized as:

–       Manufacturer of Human Medicinal Products.

–       Manufacturer of Human Medicinal Products in Research.

–       Manufacturer of Medical Devices

The totality of medicines manufactured are sterile injectable solutions of large volume hospital sale, always packaged in flexible bags of PVC or PVC free.

 

Own manufacturing

 

Altan Bernedo dedicates part of its activity to the manufacture and marketing of several own registration products used in basic fluid therapy. Also, they inject solutions with added value active ingredients, packed in flexible bag (PVC or PVC free).

  • Physiological saline solution.
  • Glucose solutions.
  • Lactacto ringer.
  • Imidazole derivatives.
  • Other antibiotics.
  • Analgesics.

 

Manufacturing of “ another type of products”

 

Actually, Altan Bernedo manufactures injectable solutions with added value active ingredients, packed in a flexible bag (PVC or PVC free), for numerous laboratories of international prestige, acting as a partner in the development and manufacture.

  • Imidazole derivatives.
  • Other antibiotics.
  • Analgesics.

 

Quality and microbiological control

Altan Bernedo through its department of QUALITY CONTROL offers the possibility to carry out all kinds of physical-chemical controls on:

  • Starting Materials.
  • Conditioning Materials.
  • Bulk Solution (Process Controls).
  • Final product.

It also has a MICROBIOLOGY Laboratory where the necessary tests are carried out on:

  • Starting Materials.
  • Bulk Solution (Process Controls).).
  • Final product.
  • Bacterial Endotoxins.
  • Bacterial Challenge.

Altan Bernedo through the department of I+D offers the possibility of:

  • Realization of feasibility studies in a flexible exchange of known active substances. Galvanic formulation.
  • Realization of pilot batches of active substances conditioned in flexible bag.
  • Carrying out stability studies on an active substance packaged in a flexible bag made of PVC and PVC free.
  • Assistance in the preparation of registers.

These services are applied to the development of own and third party products.

Contact

ADRESS:
Pol. Bernedo, s/n. Ctra. Santa Cruz
1118  Bernedo, País Vasco, Spain

TELEPHONE:
+34 94 537 82 37

FAX:
+34 94 537 82 28

MAIL:   
info@altanpharma.com