CM

Contract Manufacturing

  • European cGMP compliant manufacturing sites
  • Transfer process management – analytical and technology
  • Highly skilled and experienced transfer teams
  • Superior quality of products and customer service at competitive manufacturing costs
  • Individual approach to every enquiry
  • Relevant manufacturing costs

Contract manufacturing service

In addition to manufacturing our own products, we provide a wide range of contract manufacturing services:

  • Contract manufacturing of in-bulk and finished products – we accept orders for the manufacture of medicinal products (Rx and OTC), dietary supplements and cosmetics.
  • Packaging services
  • Professional Tech Transfer project management: technology transfer & scale-up
  • Process validation services
  • Product Life Cycle Management - our team of process engineers provides full support with product and process modification
  • Stability testing during shelf life/PQR
  • Serialization Service - 2019
  • Cooperation with our Buisness Partner - POZLAB

We ensure

  • Professional order processing in accordance with the highest manufacturing standards (cGMP)
  • Individual approach to each enquiry and precise calculation of product costs and Tech Transfer
  • Highly skilled and experienced Transfer Team dedicated to your project
  • Professional Customer Service
  • Excellent product quality at competitive manufacturing costs
  • Quality assurance system compliant with cGMP requirements
  • Access to a global pool of trusted suppliers and a guarantee of competitive price for APIs, raw and packaging materials
  • Thoroughly equipped state-of-the-art high tech QC and R&D laboratories: Analytical, Microbiological In-Process Control laboratory

We provide full support in the following areas of Project Transfer, Analytics and Quality Control:

  • Management of transfer projects / transfer of technology and analytical methods for raw materials and products
  • Manufacturing process validation and re-validation – Analytical Method Validation in accordance with ICH guidelines (physicochemical and microbiological methods)
  • Manufacture of bulk and contract packaging service
  • Quality control / quality assurance / product release to market (testing of raw materials and finished dosage forms)
  • Stability testing during shelf life at different ICH storage conditions
  • Storage of product samples for stability testing
  • Development of new products in collaboration with our in-house R&D unit or external teams
  • API and raw materials supplier qualification

PROFESSIONAL PROJECT MANAGEMENT

Client
Single point of contact
for your convenience

EVALUATION
MANAGER

STAGE 1
PROJECT EVALUATION
PROPOSAL PREPARATION
AND SUBMISSION

PROJECT
MANAGER

STAGE 2
TECHNOLOGY TRANSFER AND PRODUCT LAUNCH

CUSTOMER
SERVICE MANAGER

STAGE 3
ORDER PROCESSING
AND COMMERCIAL SUPPLY
TRANSPARENT ORGANIZATION FOR YOU TO MAINTAIN A FULL CONTROL
POLPHARMA GROUP IN POLAND
5 manufacturing sites | 4200 employees



At each stage of our cooperation you will be assigned a single contact person. Our approach guarantees proper communication flow which is crucial when information is time-sensitive and accuracy is important.

Evaluation Manager will guide you through project evaluation as well as preparation of manufacturing and transfer proposal. Our individual approach to each enquiry and detailed quotations will allow you to properly estimate your budget, avoid hidden costs and keep the COGs of your product on the same level for many years.

Our Project Manager will ensure that Tech Transfer of your product will go smoothly from the kick-off meeting until product launch.

You will receive transparency and all access that you need to drive your project forward on your terms. Our Project Manager will act on your behalf to ensure that your project is completed on-time and on-budget.

Customer Service Manager will be in regular contact with you during order processing, commercial supply and change control implementation. We guarantee: speed, flexibility and on-time reliability. With our Customer Service Manager on the watch, you can rest assured that the job is getting done while you do yours.

Thanks to high responsiveness as well as effective and transparent communication of our team, you will maintain full control over your product.

Contract Manufacturing Possibilities

Solid dosage forms

Tablets

POLPHARMA SA STAROGARD GD., DUCHNICE, NOWA DĘBA

  • Multilayer tablets
  • Film and sugar coated tablets
  • MR tablets (modified release)
  • IR tablets (immediate release)
  • Enteric-coated tablets
  • ODT tablets (orally disintegrating tablets)
  • Vaginal tablets
  • Effervescent tablets
  • Chewable tablets

Hard capsules

POLPHARMA SA STAROGARD GD., NOWA DĘBA

  • Filled with: powders, pellets, granulate, granulate + tablet

Soft gelatin capsules

MEDANA SIERADZ

Liquids dosage forms

Oral liquids

MEDANA SIERADZ

  • Syrups
  • Suspensions
  • Solutions
  • Drops

Nasal drops and gels

MEDANA SIERADZ, POLFA WARSZAWA

Eye drops

POLFA WARSZAWA

  • Single and multi-dosage products
  • Solutions
  • Suspensions
  • Products with no preservatives

Sterile injections and infusions

Solutions and emulsions in glass ampoules

POLPHARMA SA STAROGARD GD, POLFA

Solutions and emulsions in glass vials

POLPHARMA SA STAROGARD GD, POLFA, DUCHNICE

LDPE Small Volumes Parenteral (BFS)

POLPHARMA SA STAROGARD GD, POLFA

LDPE Large Volumes Parenteral (BFS)

POLPHARMA SA STAROGARD GD, POLFA

Pre-filled syringes

POLFA

Semisolids dosage forms

Topical Products and Cosmetics

MEDANA SIERADZ

  • Gels
  • Emulsions
  • Ointments
  • Shampoos
  • Antifungal nail polish

Manufacturing sites located in Poland

Starogard Gdański

medana pharma sa

sieradz
Specialization: Paediatric medicines, vitamin products and food supplements
Annual Capacity:

600 mln units of soft gel capsules
50 mln units of non-sterile liquids
9 mln units of semisolides

gel capsules non-sterile liquids semisolides

Sieradz

medana pharma sa

sieradz
Specialization: Paediatric medicines, vitamin products and food supplements
Annual Capacity:

600 mln soft gel capsules
48.7 mln units of non-sterile liquids
9 mln units of semisolides

gel capsules non-sterile liquids semisolides

Nowa Dęba

pharma sa

manufacturing branch in nowa dęba
Specialization: Solid dosage forms
Annual Capacity:

3 bln units of tablets
1 bln units of hard capsules

tablets hard capsules

Duchnice

polpharma sa

manufacturing branch in duchnice
Specialization: Cefalosporins
Annual Capacity:

30 mln units of tablets
15 mln units of sterile powders

tablets sterile powders

cGMP unique technological solutions

We are among the largest and most modern pharmaceutical factories in Europe. The annual production capacity of the works is 5 billion solid-form drug units (tablets, capsules) and 190 million liquid-form drug units (injectables in polyethylene containers and glass ampoules and infusion solutions and solutions for topical use).

  • 36.752 m² total area
  • 3.500 m² class D manufacturing
  • 9375.2 m² total production area





Wide range of capsules’ sizes and shapes

We are among the leaders of pediatric medicines, vitamin products and food supplements suppliers.

We offer a number of products to be manufactured with our already developed technology:

  • Shark liver oil + Vitamin E caps.
  • Shark liver oil + garlic macerated oil caps.
  • Primrose seed oil caps.
  • Flax oil caps.
  • Omega 3 caps.
  • Omega 3-6-9 caps.
  • Vitamin D3 caps.
  • Vitamin D3 + Vitamin K caps. (twist - off)
  • Vitamin E caps.
  • Cranberry extract + Vitamin C caps.





We specialize in solid dosage forms and food supplements such as tablets and hard capsules.
Highly efficient modern machines and manufacturing equipment and well-fitted laboratories with experienced highly-qualified staff guarantee an effective management and the implementation of difficult projects.

  • High-bay storage warehouse
  • Administration & QC
  • Formulation Unit
  • Packaging Unit



Manufacturing Division in Nowa Dęba is providing services:

  • Pilot batch production (starting from 10 kg)
  • Trial batches manufacturing
  • Manufacturing bulk product (tablets, dragees, hard caps)
  • Packaging
  • Validation and re-validation of analytical methods
  • Carrying out analytical, microbiological tests
  • Analitycal development
  • Stability testing in different climatic conditions (ICH, ongoing)
  • Storage of product samples for stability testing
  • Storing and release to the market





Polpharma’s Manufacturing Branch in Duchnice near Warsaw is specialised in the manufacture of antibiotics.

We manufacture first-, second- and third-generation cephalosporins (both injectable and oral dosage forms) in pediatric and adult doses.