Manufacturing
Manufacturing at Antibiotic-Razgrad AD is organized to ensure consistency, control, and traceability at every stage of the process. The company’s operations bring together manufacturing facilities, quality assurance, and laboratory control within one integrated system.
Following development and registration, products move into manufacturing implementation. Each process is managed in accordance with applicable regulatory requirements, internal standards, and approved documentation.
Manufacturing Facilities
The manufacturing facilities are located in Razgrad, Republic of Bulgaria, and are intended for the production of various pharmaceutical dosage forms. They are designed, constructed, and validated to ensure the quality of the processes and products.
Manufacturing activities are carried out:
- ● Under conditions supported by modern utility systems ●
- ● Using equipment fitted with the necessary systems for monitoring critical process parameters ●
- ● Through reliable in-process control ●
Key Manufacturing Technologies
Antibiotic-Razgrad AD has specialized manufacturing facilities for a variety of pharmaceutical dosage forms. Controlled processes ensure consistent quality at every stage of production.
Solid oral dosage forms:
- Capsules
- Tablets;
- Granules and powder for oral use;
Conventional technologies are applied - sieving and measuring a production recipe, dry mixing, wet granulation, tableting, tablet film coating, filling into hard gelatine capsules, filling into sachets.
Eye drops
The facilities are equipped with advanced equipment for the production of sterile eye drops according to EU GMP Annex 1 requirements . The solutions are obtained by sterilizing filtration. Dosing is carried out in aseptic conditions, ensured by a system RABS. The quantity in a vial is from 2.5ml to 10 ml.
Semi-solids forms:
- Eye ointments
- Creams, gel and ointments
The production process goes through measuring starting materials for a batch of product, melting, homogenization, filling into tubes. The method used to ensure sterility of eye ointments is thermal sterilization.
The dosage of eye ointments is in sterile aluminium tubes of 3 to 5 grams, in a category A zone, with a category B surrounding environment. Dermal semi-solid forms are dosed in the range of 5 to 100 grams, in aluminium tubes.
From Manufacturing to Market
Following manufacturing and quality control, finished products proceed to release and market distribution. Antibiotic-Razgrad AD maintains marketing authorizations in more than 25 countries and develops and registers new products every year.
