A regulated production environment for medicines and APIs.

Balkan Pharma Industries manages pharmaceutical manufacturing, QA/QC, R&D, regulatory documentation, and traceable delivery for B2B partners.
Specialists in protective suits working inside a cleanroom
Founded
1991
Team
501-1K employees
Experience
30+ years
Standard
GMP production environment

Control documentation

QA system

Validated processes, controlled documentation, and deviation management.

QC laboratories

Laboratory control, checks, and batch release support.

Regulatory affairs

Dossiers, certificates, analysis, and market documentation.

Patient safety

Decisions are evaluated through safety, efficacy, and compliance.

Operating record

StageOwnerOutput
R&Dtechnology teamdevelopment, transfer, assessment
Manufacturingproductionseries, environmental control, packaging
QA/QCqualityvalidation, analysis, release
Regulatorydocumentationdossier, certificates, market requirements
Supplylogisticsserialization, traceability, delivery

Capability register

Generic medicines

Solid-dose manufacturing and controlled specifications

regulatory dossier

APIs

Active pharmaceutical ingredients for partner markets

certificate and analysis

Contract manufacturing

Production to partner specification

GMP documentation

Serialization

Identification, packaging, and traceability

market compliance

The batch stays traceable to market.

Serialization, controlled documentation, and logistics procedures support deliveries to Europe and selected international markets.

Regulatory contact

Send the product type, target market, and documentation need.
Troyan, Lovech 5600, Bulgariapartnerships@balkan-pharma.org
Product
generic product / API / contract manufacturing
Market
target market and regulatory regime
Evidence
GMP, analysis, serialization, dossier