High potent solids

Oncology | Hormones and Hormone-like

Aenova has an excellent track record in developing and manufacturing drug products containing high potent APIs up to OEB 5.

We are partner of choice for novel/innovative product solutions as well as commercial high-volume manufacturing high-potent drug product manufacturing.

Aenova’s high potent API production solutions feature dedicated plants, applying high safety equipment and state of the art API risk management concepts that ensure full protection of product, patients and environment. All of our high-potent API plants have a comprehensive record of global GMP inspections.

Our full-service manufacturing and supply-chain services are integrated with our development / technical transfer / analytical services.

Oncology - high potent solids

Our oncology drug product manufacturing includes virtually all solid dosage forms and all key manufacturing technologies variably arranged. Batch sizes range from 0.5-500 kg. We also offer customer-specific ‘plant-in-plant’ solutions.

For oncology products Aenova has an excellent track record and long-standing experience in development and production of novel/innovative drug products as well as generics.

Capacity: >1.5 billion
OEB level: 3-5

Hormones / hormone-like – low-dosed high potent solids

Bulk manufacturing solutions offer highly efficient closed-containment equipment trains. Packaging services include product-specific blister solutions, e.g. oral contraceptives. Our high-potent API plants have world-wide GMP approvals.

For low-dosed high potent APIs (hormones and hormone-like substances) Aenova has an excellent track record and long-standing experience in development and production of novel/innovative drug products as well as generics.

Capacity: >3 billion
OEB level: 3-5

Product Features
Locations

APIs

Oncology

  • Cytotoxic
  • Cytostatic
  • Immuno-modulating

Hormone/hormone-like

  • Sexual hormones
  • Cytostatic hormones and antagonists
  • Corticoids/corticosteroids,
  • Thyroid hormones

Dosage forms

  • Tablets
  • Hard capsules
  • Film-coated tablets
  • Sugar coated tablets

Product types

  • Rx
  • OTC

Services

  • Full-service manufacturing
  • Customer-specific supply chain services
  • Development services
  • Technology transfer
  • Analytics services

Packaging

  • Bulk
  • Tubes
  • Sachets
  • Sticks/stripes

Certifications

  • EU GMP
  • US FDA
  • ANVISA
  • Belarusian MoH
  • Iranian MoH
  • Kenyan MoH
  • Korean MoH
  • Libyan MoH
  • Russian MoH
  • Turkish MoH
  • Ugandan MoH