Contacts

UAB Biotecha

P. Vileišio g. 17A,
10306 Vilnius, Lithuania
Tel.:  +370 5 237 60 07 
E-mail: info@biotecha.lt

Raw materials for industry

Raw production materials for hard, semi-hard (soft) and liquid dosage forms. Smart and functional excipients for medicines. A wide selection of raw materials. Services for the development of medicine formulations and launching their production.

Solid dosage forms

The development of medicines in solid forms with controlled functions is one of the key tasks of the modern pharmaceutical industry. It requires innovative approaches and appropriate formulations. We offer everything for the production of solid dosage forms, including excipients and additives, lubricants, binders, fillers, sucralose, and many other applications adapted to your products. In addition, we offer the benefit of our years of experience in developing new products and improving the products already produced.

Semi-solid pharmaceutical forms

Our solutions and the necessary means for semi-solid dosage form formulation, development and manufacturing processes will provide more room for flexibility and creativity. They include gelatin agents, antioxidants, moisture enhancers and targeted acidification products. Solubility and stability can be achieved by using surfactants or natural adhesives. Our preservatives meet all pH requirements.

Liquid dosage forms

Merck has vast experience in the technology of liquid pharmaceutical dosage forms. We provide high-quality products and the best solutions, meeting all quality requirements of the pharmaceutical industry for the production of syrups, nose/eye drops, tinctures, ointments, salines or injections. In addition, we have a wide range of solvents, preservatives, pH modifiers and stabilizers.

EMPROVE® program – easier risk assessment

As a supplier of raw materials and industrial materials for the pharmaceutical and biopharmaceutical industries and medicinal formulations, Merck pays great attention to the compliance of the supplied products with the latest regulations and for ensuring uninterrupted operations of its customers. With increasingly stringent risk assessment guidelines and directives applied for these industries, the updated EMPROVE® program of Merck and the structure and content of the dossier of suppliers meets the latest regulations, to accelerate clients’ processes in the control and supervisory labyrinths.

All EMPROVE® products are supplied with comprehensive documentation, to reduce the costs for qualification and registration processes, and to help accelerate the integration into the market. Using EMPROVE® raw materials you will have everything necessary for the successful registration of medicinal products.

EMPROVE® program covers about 400 raw and industrial materials, including excipients (additional substances), chemicals used in production and active pharmaceutical ingredients (API) used in medicinal preparations.

Program and structure of the dossier

EMPROVE® classified products are grouped by degree of risk.The documents of each EMPROVE Essential and EMPROVE® Expert product are divided into three possible options of the dossier. This facilitates product qualification, risk assessment and process optimization. For active pharmaceutical ingredient EMPROVE® API gives access for documentation (DMF ASMF, CEP) approved by relevant authorities.

The recent EMPROVE® program upgrade enabled the selection of raw materials and industrial materials according to application, depending on the degree of risk:

  • EMPROVE® Essential products for medium-risk category applications.
  • EMPROVE® Expert raw materials and production materials for the applications of higher degree of risk, with extremely critical low microbial and endotoxin contamination levels. The manufacturing process of our products is designed so that we can ensure low microbial and endotoxin contamination levels of our suppliers.
  • EMPROVE® API products are delivered with quality confirmations and other documents complying with the legal provisions, required for active pharmaceutical ingredients. Substances are produced in Europe in accordance with the ICH Q7 Directive, the products meet the GMP requirements.

 

 Material qualification dossier¹Quality management dossierOperating activities dossierDMF, ASMF, CEP
Emprove® EssentialXXX 
Emprove® ExpertXXX 
Emprove® API   X

¹ Material qualification dossier: former Main dossier. 

Gazele 2013   Gazele 2015


© Biotecha UAB, Vilnius, Lithuania, 2013