- Europe, North America, …
- Germany, Denmark, …
- Human Medicines, Biopharmaceuticals, …
- Service category
- Contract manufacturing, filling and packaging, Formulation development and drug delivery, …
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- Analytical service / development / validation
- Contract manufacturing
- Pilot scale
- Project management
- Regulatory services
From Evaluation to Registration
PharmaZell offers a wide range of API related services for different phases of the drug development process – both for originators in the pharmaceutical industry and for producers of generic drugs as well.
These services are based on a global network of state-of-the-art facilities and experienced personnel engaged in the various disciplines required to make pharmaceutical commercialization successful and efficient.
Our organizational capabilities have been set-up to address the commercialization process of the global pharmaceutical companies – providing manufacturing, services and consultation from early phases needs for pre-clinical and clinical trials to full scale commercial launch of drugs.
PharmaZell does have the needed process in place to develop speedy responses on project feasibility inquiries and manages the entire process from the first few amounts of an API to the successful commercial production of the target compound.
Depending on the needs of our customers, our services can be provided as comprehensive solutions or in modular form and it is up to our customers to decide for either distinctive parts or package solutions. Once the scope is defined and agreed, we build each team around the unique requirements of the project and the customer.
A dedicated project manager is assigned and a detailed development agreement as well as a mutually shared project plan set high standards and define the scope and timelines. The mode of interaction with our clients is agreed upon mutually in the beginning of the project and contains typically regular (weekly) project meetings via phone as well as regular e-mail status reports. Upon the completion of project work, final project reports are issued.
Our account managers work closely together with our technical project managers, ensuring project teams are aligned and that our clients have a complete understanding of the project status at any time.
PharmaZell is a small but specialized and accessible organization and therefore easy to communicate and do business with. We are open and transparent and understand the importance of listening to our customer's needs and acting accordingly.
Finished Dosage Form
- Solubility, pH, solution stability
- Moisture content, sorption analysis
- Thermal analysis (thermal behaviour, melting point).
- Structural characterization - FTIR, UV/Vis, fluorescence, NMR, MS Particle morphology, size and size distribution
- X-ray powder diffraction (XRPD)
- Polymorph screening
- Solid state stability
- Drug-excipient compatibility and packaging component compatibility
- Tablets (Immediate, modified release mono layered and bilayer)
- Particulate, film, enteric coating
- Oral Solutions and suspensions
- Powders-blends and Sachets
- Bottle, blister, sachet and tube packaging
- Clinical supply and placebo manufacture
- Review of batch documentation by developmental Quality Assurance team
- Informal and formal studies (ICH)
- Including elevated, ambient, and subambient
- Temperatures, photo stability
- Degradation studies-temperature, pH, light, oxidation
chemistry and/or suggest, develop and optimize alternate synthetic routes. PharmaZell will provide you with the appropriate solution to meet your expectations on quality, quantity and regulatory needs within the relevant timeline requirements.
Our process development services include:
- Chemical route selection
- Process optimization and scale-up
- HSE assessment
- Process validation
- Development of analytical methods and validation
- Regulatory filings
Our services include all areas of Advanced Intermediates and API product development and cGMP compliant manufacturing – from few grams to multi-ton scale.
In addition, we offer API particle control (i.e. polymorphism, tailor-made particle size distributions and crystall shape) via optimization of crystallization processing, drying and/or milling and micronization.
PharmaZell provides a wide range of diverse technologies, such as batch and continuous processes (including micro reactor technology) numerous chemical reactions like nitrations, halogenations, hydrogenations, electrochemical reactions, electrodialysis and reactions with organo-metallic compounds, etc.
Furthermore we offer solutions for stereoselective synthesis problems by applying biocatalytic/enzymatic reaction expertise.
Our analytical R&D (AR&D) teams support the process development groups with the following activities:
• Reference standard qualification
• Development and validation of analytical methods
• Final product testing
• Stability studies according to ICH guidelines
All development centers do have state-of the-art instrumental analysis equipment available and in use. For HPLC analytical methods, there is a number of different detectors available (UV, DAD, RI, ELSD) in order to support the product specific requirements.
For physical parameter testing, Sympathec and Malvern Laser equipment for the determination of the particle size distribution is available.
Pilot Scale Manufacturing API
PharmaZell operates on every site a pilot plant to
- ensure a seamless transfer from lab-scale development to commercial production
- produce APIs under cGMP for clinical supply
- manufacture small scale commercial batches
We can meanwhile look back to many years of scale-up experience which guarantees that process optimization will incorporate all safety and efficiency aspects.
Key characteristics PharmaZell's pilot plants
- cGMP compliant documentation and equipment
- Finish product handling/ drying in controlled areas
- Multiple reactor sizes ranging from 50 to 2000 L
- Agitated pressure filters, centrifuges and nutsches
- acid and alkaline resistant equipment
- Temperature ranging from - 80°C to 250°C
- Pressure ranging from 2mbar to 40 bar
- Plug flow reactor
Pilot Scale Manufacturing FDF
PharmaZell (Vizag) operates a pilot plant for formulations to
- Ensure technology transfer from Lab development to Pilot/ Pivotal scale up, inline simulation to commercial scale production
- Produce formulations Exhibit/ Submission/ Pivotal batches under cGMP for BA/BE studies
- Conduct stability studies as per the ICH and regulatory requirements
- manufacture small scale commercial batches (high value products, which are usually required in small batch sizes).
We contribute a scale-up experience which guarantees the process optimization as per all regulatory guidelines with all safety and efficiency aspects.
Key characteristics of Pilot/Pivotal Plant
- The Facility is a class 1,000,000 area with a cGMP compliant documentation and equipment
- Separate well-equipped and demarcated rooms as material hold area, granulation area, compression room, a coating room, IPQC room, primary and secondary packaging room and wash area.
- Capable of taking up batch size up to 15 kg to 75 kg.
- Capable of wet/dry granulation, direct compression, film coating and blister/strip/alu-alu packing of oral solid dosage finished products.
- Analytical method validations.
- Validation studies for Pilot/ Pivotal
- Dossier registration support to all regulated and ROW markets
- Product launch after patent expiry
- Absolute focus on Safety, Health & Environment
- Having space for new/ novel drug delivery systems like technology platforms (modifier release, delayed release, dry syrups)
For all commercially manufactured products PharmaZell holds Drug Master Files (DMFs) and/or Certificates of Conformity with the European Pharmacopeia (CEPs) with health authorities in the US, Europe, Japan, Canada and Australia for all active pharmaceutical ingredients.
This extensive experience in Regulatory Affairs over many years in combination with PZ’s process development expertise can carry customer’s projects fast all the way till successful product launch.
Concurrently during the development process stages relevant data for Chemistry, Manufacturing & Control (CMC) documentation are compiled and prepared for filing. Regulatory assistance is given in all aspects of customer product including meeting with regulatory agencies to discuss manufacturing and testing issues.
The registration dossiers are maintained in close cooperation with the customer during the life-cycle of a product. This includes adaption of dossiers to state of the art technologies.
These documents are prepared during product development, submitted to the authorities, maintained and updated during the life cycle of the products. PharmaZell's sites are regularly audited by competent authorities.
PharmaZell’s experience in manufacturing a very wide range of chemicals and API’s has developed over many decades and allows us now to quickly come up with solutions to virtually all types of chemical and other problems that we handle for our customers.
Being able to develop and produce at different sites with different histories and different capabilities gives us the highest degree of flexibility in production. Multi-step synthesis’ can be worked on simultaneously at different sites which allows for the fastest possible new product introduction and - if one of our Indian sites is part of the supply chain - leads to economic advantages for both PharmaZell and our customer.
The wide range of technologies that the PharmaZell group has in its portfolio allows us to produce most of the known API’s. Also niche technologies such as electrolysis on a large scale and controlled substances are part of our knowhow. And, of course, we constantly enlarge our portfolio of technologies.
As a leading chemical manufacturer of small molecule actives and advanced intermediates, PharmaZell has been supplying the pharmaceutical industry for years with Active Pharmaceutical Ingredients (APIs) in a wide range of specifications covering the quality requirements of various formulations and markets. No matter what solutions customers may require for their formulations: PharmaZell will provide comprehensive support during development, registration and production. PharmaZell‘s development pipeline continues to expand just like its range of generic APIs manufactured on an industrial scale.
PharmaZell manufactures a wide range of generic active substances in its four GMP manufacturing sites. These substances are supplied to the pharmaceutical industry globally. Due to its flexible manufacturing structure the API quantities supplied by PZ range from few kg´s to several hundred tons of individual API´s.
Many substances are available in various physical forms or particle sizes tailored to meet the formulation requirements of our customers.
PharmaZell holds DMF´s /ASMF´s / CEP´s for all its commercially available generic active ingredients. These documents are submitted to all relevant health authorities around the world.
Products under Development
PharmaZell is continuing to expand its range of active ingredients continuously by developing new manufacturing processes.
PharmaZell supplies a wide range of amino acids tailored to fit the requirements of numerous applications in the pharmaceutical, neutraceutical and personal care industry. PharmaZell can also manufacture and provide numerous derivatives of those and other amino acids.
PharmaZell manufactures APIs under cGMP. The majority of our products can be provided in various particle sizes to meet customer needs.
Approvals, Certificates, Authorisations
- Danish Health Authority
- Japan PMDA
- US FDA 21 CFR 210
- ICH Q7A
- EU GMP Guideline Part II
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