Sopharma as a partner

Through tradition and modern approach to production, meeting the EU quality standards and developing corporate social responsibility, Sopharma has been producing products of the highest quality standards for 85 years.

Sopharma is a holder of EU GMP - certified manufacturing sites for different dosage forms with the assurance for high product quality.

More than 200 different products are produced by Sopharma’s pharmaceutical manufacturing plants and distributed to 40 countries for various international partners.

Sopharma offers:

• EU-GMP compliant pharmaceutical contract manufacturing,
• EU primary and secondary packaging services for international markets,
• Development of various dosage forms,
• Technological transfer of customer-developed products,
• Cleaning validation, Process validation,
• EU batch release and batch control.

Sopharma is specialized in:

• manufacturing of solid and semi-solid dosage forms,
• sterile dosage forms,
• non-sterile liquids/solutions.

These are all of which produced in specialized facilities (for suppositories, tablets, lyophilized products, ampoules, phyto-APIs manufacturing, syrups, creams, ointments and gels).

All the plants are EU GMP-certified and they are able to produce different types of packaging based on customer demands:

• packaging in bags,
• packaging in containers,
• packaging in AL/ PVC, AL/ PVDC, ALU/ALU blisters,
• packaging in carton boxes,
• packaging in bottles,
• packaging in tubes,
• shippers packaging.

The plants can also handle specific packaging items like Data Matrix Code, Braille, Vignettes etc.

The capability of the organization and its facilities capacity is a guarantee for a high quality affordable product in a timely manner.

Sopharma offers the following contract manufacturing services:

Tablets, film-coated tablets, sugar–coated tablets and hard-gelatin capsules 

The tablet plant has an advanced manufacturing capacity, a plentitude of technological experience and a committed and highly qualified team. We are capable of manufacturing a large variety of tablet shapes and sizes. Upon demand, customised tablet shapes can also be manufactured. Tablets can be coated according to customers’ needs, using film or sugar coatings.

Main manufacturing equipment includes:

• fluid bed dryers,
• blenders,
• film-coating drums,
• high shear mixers,
• tablet presses – FETTE,
• packaging lines Uhlmann and
• capsule filling machine MG2 Planeta.

Sterile injectables (terminally sterilized injectables and aseptically prepared injectables)

At any stage of the production, from the filling to the packaging, we can offer pharmaceutical contract manufacturing services for the following pharmaceutical forms: glass ampoule of 1, 2, 5 and 10 ml, 100, 250,500 and 1000 ml PP bags and 0.7÷ 500 ml BFS (blow fill seal manufacturing technology).

Main manufacturing equipment include PW installation and WFI installation (used jointly with the lyophilized products plant), lines for fully automated dosing and soldering lines for glass ampoules and PP containers, fully automated lines for grading manufactured products (particulate matter check and container hermetability test), labeling machines and automated secondary packaging lines (placing the containers in blisters with information medium and in boxes).

Depending on the nature of the medicinal products, they can be produced in three ways:

• In a final sterilization module where the main stages are: preparation of the medicinal solution in containers, washing dosing and soldering of ampoules by automated line (involving PW and WFI systems), final sterilization in autoclaves of the product.
• In an aseptic module where the main stages are: preparation of the medicinal solution in containers, washing dosing and soldering of ampoules by automated line (involving PW and WFI systems), sterilization of the product by sterile filtration during dosing.
• Sector Lyophilic products, where the main stages are: preparation of the medicinal solution in containers, washing and dosing of ampoules by automated line, sterilization of the product by sterile filtration during dosing, lyophilization of the product in a lyophilic installation and soldering of ampoules by automated line (involving PW and WFI systems).

Suppositories

We offer suppository products of high quality at economical prices in bilayer PVC/PE packs.
Main manufacturing equipment includes:

• homogenizers,
• vessels,
• filling and
• packaging line.

Non-sterile dosage forms (solutions)

Sopharma offers non-sterile dosage forms (syrups) in a variety of final packages, including PET and glass bottles.
Main manufacturing equipment includes vessels, primary and secondary packaging lines.

Semisolid dosage forms

Sopharma plants are able to manufacture different topical products (creams, ointments and gels).

Main manufacturing equipment includes vessels, homogenizer, filling and packaging line for Al and laminate tubes with filling head for 5 ÷ 150 ml and tube holders with a 20 mm diameter.