PharmIdea Contract Manufacturing of Sterile Drugs in Vials and Product Development

PharmIdea is an independent pharmaceutical company located in Latvia (EU).

We offer contract manufacturing as well as contract development of pharmaceutical products with the main focus on sterile products (solution or freeze-dried formulation) in vials. PharmIdea’s manufacturing site is GMP certified to also produce cytotoxic products.

Contract manufacturing of sterile products

PharmIdea’s services include incoming materials control, small batch size manufacturing under GMP conditions including manufacturing of investigational medicinal products, in process control as well as final product release. Altogether three different manufacturing processes can be employed in the sterile manufacturing facility:

  • Aseptic filtration with terminal sterilisation
  • Aseptic filtration and processing of solutions
  • Freeze drying

The average batch size is 1,500 vials for freeze-dried products and 3,500 vials for solutions. The volumes of vials available are 1ml–100ml. PharmIdea applies class A (ISO 4/5) isolator to ensure vials processing under aseptic conditions. Modern manufacturing and analytical equipment and a GMP approach guarantee an efficient and reliable service.

Clinical trial material (CTM) manufacturing (sterile products in vials)

PharmIdea’s clinical trial material (CTM) manufacturing services include:

  • Product formulation development
  • Investigational medicinal products GMP manufacturing for Phase I – III studies
  • Clinical trial material labelling, release, dispatching and shipping

Final dosage forms (FDF) development services

PharmIdea formulation services include:

  • Pre-formulation and formulation of sterile solutions, freeze-dried forms as well as solid oral dosage forms (tablets and capsules)
  • Lab-scale batches manufacturing
  • Scale-up and validation batches manufacturing under GMP conditions
  • Stability studies according ICH guidelines
  • Container closure integrity tests
  • CTD format dossier development for product registration in the EU

Active pharmaceutical ingredients (API) development

PharmIdea has experience in active pharmaceutical products development and our services are listed below:

  • Patent situation check and freedom to operate verification
  • Synthesis route development
  • Scale-up and process validation
  • Validation batches manufacturing under GMP conditions
  • API stability studies according to ICH guidelines
  • Active substance master file preparation
  • Selection of industrial manufacturer

Analytical services for API and FDF

PharmIdea offers the following analytical services for both API and FDF:

  • Analytical methods (related substances, assay, identification, dissolution) development and validation according to ICH guidelines
  • Forced degradation studies
  • Microbiological limit method development and validation
  • Sterility method development and validation
  • Bacterial endotoxines test method (gel -clot) development and validation

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Press Release

PharmIdea to Attend CPhI Worldwide

Pharmidea has announced it will participate in the CPhI Worldwide, a leading pharmaceutical exhibition in Feria de Madrid, Spain.

White Papers

PharmIdea Company Brochure

PharmIdea's vision is to become internationally recognised as a pharmaceutical company that provides high-quality, self-produced generic hospital, women's health and anti-cancer drugs with competence in research and development (R&D) and sterile formulations. 

Address
PharmIdea

4 Rupnicu Str.

LV-2114

Olaine

Other

Latvia

+371 67 069 889 +371 67 069 848 www.pharmidea.lv

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Press Release

4 October 2018

Pharmidea has announced it will participate in the CPhI Worldwide, a leading pharmaceutical exhibition in Feria de Madrid, Spain.

Read more

Regional Offices

PharmIdea

4 Rupnicu Str.

LV-2114

Olaine

Other

Latvia

+371 67 069 889 +371 67 069 848 www.pharmidea.lv

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