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Recipharm

RTP, North Carolina, US

Recipharm was established in Sweden in 1995 and has since grown to become a leading Contract Development and Manufacturing Organisation (CDMO). Headquartered in Stockholm, we employ nearly 5,000 people and the Recipharm B-share (RECI B) is listed on NASDAQ Stockholm.

For over 20 years we have focussed on supporting pharmaceutical companies in taking their products from early development through to commercial manufacturing. Throughout the entire product lifecycle, we are there for our clients. Time and time again, we have delivered innovative solutions.

We’ve been around for a while and we’re proud of the company we’ve built which is why we want you to know we are here for you today and we’ll be here for you tomorrow too. That’s the Recipharm way.

There are lots of CDMOs in the world. But none quite like Recipharm. Despite the scale and size of our company, we conduct our business in the right way, by... Show more »

Recipharm was established in Sweden in 1995 and has since grown to become a leading Contract Development and Manufacturing Organisation (CDMO). Headquartered in Stockholm, we employ nearly 5,000 people and the Recipharm B-share (RECI B) is listed on NASDAQ Stockholm.

For over 20 years we have focussed on supporting pharmaceutical companies in taking their products from early development through to commercial manufacturing. Throughout the entire product lifecycle, we are there for our clients. Time and time again, we have delivered innovative solutions.

We’ve been around for a while and we’re proud of the company we’ve built which is why we want you to know we are here for you today and we’ll be here for you tomorrow too. That’s the Recipharm way.

There are lots of CDMOs in the world. But none quite like Recipharm. Despite the scale and size of our company, we conduct our business in the right way, by respecting all stakeholders at all times and delivering value for money to our clients.

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API Sourcing
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Solid Dosage Formulation
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Topical Formulation
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ICH Stability Testing
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Drug Preformulation
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Preformulation is a key activity in order to prepare for formulation of clinical trial material as well as final product.

Our preformulation services include:

  • Solubility profile and solubility enhancement
  • Determination/optimization of partition and
  • Distribution coefficients (logP, log D), pKa, pH, etc.
  • Excipient... Show more »

Preformulation is a key activity in order to prepare for formulation of clinical trial material as well as final product.

Our preformulation services include:

  • Solubility profile and solubility enhancement
  • Determination/optimization of partition and
  • Distribution coefficients (logP, log D), pKa, pH, etc.
  • Excipient compatibility screening
  • Stability studies
  • Solid state characterization (in collaboration with partner)
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Clinical Trials Supply Manufacturing
Price on request

Within our dedicated development facilities, we have cleanrooms for the cGMP production of solid, liquid and semi-solid formulations and a sterile suite for the production of sterile vials. Our development facilities allow us to cater for a range of clinical trials from preclinical to smaller Phase III trials. Efficient sourcing... Show more »

Within our dedicated development facilities, we have cleanrooms for the cGMP production of solid, liquid and semi-solid formulations and a sterile suite for the production of sterile vials. Our development facilities allow us to cater for a range of clinical trials from preclinical to smaller Phase III trials. Efficient sourcing of raw materials guarantees that there are no unnecessary delays. For very large clinical batches we can arrange manufacture in one of our commercial manufacturing units. So whatever stage you’re at, we can support your project.

Non-sterile production

Our labscale equipment is suited to your preclinical or Phase I material. The pilot-scale equipment is suitable for Phase II and smaller Phase III trials. The dosage forms range from pure API in capsules or granulates in sachets, to more advanced controlled release products. For coated pellets we have a specialised development unit where we have the ability to produce GMP batches for clinical trials from Phase I to full commercial batch size.

Sterile production

Our sterile suite consists of a Grade C area where the solution preparation takes place. This includes the rinsing of vials and the loading of the autoclave and dry heat steriliser. Grade B is compatible with a filling machine (ROTA), a crimping machine and an LAF (Holten) for manual filling.

The size of this sterile suite is perfect for customers looking for smaller batches. The ROTA filling machine is validated for 10, 20, 50 and 100 mL vials. The batch size is limited by the dry heat steriliser with room for approximately 700 of 100 mL vials and up to 3000 of 10 mL vials. If hand-filling is required for small batches, unusual containers, sensitive or very expensive material, this can be done in our LAF, Grade B.

Our Part 11 validated Facility Monitoring System keeps track of temperature, humidity and pressure as well as recording particles, online. We also have in-house WFI and clean steam.

Packaging and labelling

We perform packaging and labelling of active and placebo material as needed for your trial.

Quality Control

Our development units have onsite QC labs working in close collaboration with the analytical chemists that develop our analytical methods.

Qualified Person

We have in-house QA and QP who are accustomed to clinical trial material and the diversity between one batch and the next. We perform QP release and we can offer audits of DS suppliers.

Clinical trial distribution

Storage and distribution services for clinical trials are offered in collaboration with a partner. This includes distribution all over the world through a network of depots in four continents.

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Pharmaceutical Formulation
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Our highly skilled formulation development team has the capability to manage a pharmaceutical project from the preclinical stage to full scale commercial manufacturing.

We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation. At each stage of the development... Show more »

Our highly skilled formulation development team has the capability to manage a pharmaceutical project from the preclinical stage to full scale commercial manufacturing.

We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation. At each stage of the development process we are committed to achieving the right quality as quickly and cost effectively as possible. Our expertise in scale-up and industrialisation ensures that the final product will be suitable for large scale manufacture and commercialisation.

Our formulation development services include:

  • Sourcing of excipients and API
  • Pre-formulation studies
  • Automated formulation screening
  • Drug substance and excipient compatibility studies
  • Early screening for structural and chemical stability
  • Development of formulations for preclinical studies and clinical studies Phase I to III
  • Manufacturing of batches for stability studies
  • Development of formulations for application of marketing authorisation
  • Scale-up and pilot scale manufacturing
  • Technology transfer and process validation
  • Compilation of CMC regulatory documents

In conjunction with the above, we can develop a number of different dosage forms including:

  • Capsules, coated capsules, capsules filled with coated or un-coated particles
  • Coated pellets
  • Formulations for poorly soluble drugs
  • Liquids such as oral and topical, solutions, suspensions and emulsions
  • Ophthalmic products
  • Parenteral formulations
  • Powders and granules
  • Inhalation and nasal product development
  • Rectal formulations
  • Tablets, immediate-release tablets, mini-tablets, coated tablets, effervescent tablets, enteric-coated tablets, sustained release tablets
  • Topical and transdermal formulations
  • Vaginal formulations

We also have platform technologies to assist/improve drug delivery and formulation development:

  • Metal coordinated pharmaceuticals – in collaboration with Synthonics Inc. we offer a new method to improve physicochemical and pharmacokinetic properties of drugs.
  • Polymers for parenteral applications - we have the capabilities to develop and GMP manufacture polymers for use in sterile dosage forms.
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Chemical Stability Testing
Price on request

We design and execute protocols for technical, clinical and ICH stability studies applicable for the relevant stage of the project. The samples are stored at long term and accelerated conditions according to the ICH guidelines with a CFR part 11 compliant monitoring system.

After analysis, we provide stability reports suitable... Show more »

We design and execute protocols for technical, clinical and ICH stability studies applicable for the relevant stage of the project. The samples are stored at long term and accelerated conditions according to the ICH guidelines with a CFR part 11 compliant monitoring system.

After analysis, we provide stability reports suitable for the customer and the regulatory authority. Due to our vast experience in stability studies we can guarantee your projects will be handled efficiently by dedicated staff.

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Analytical Method Development
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Our laboratories develop assays to address for identity, strength and purity of products and raw materials as well as developing stability indicating assays. Our cGMP compliant facilities are equipped with state of the art technology to ensure rapid and accurate product characterisation and method development. This includes:

-... Show more »

Our laboratories develop assays to address for identity, strength and purity of products and raw materials as well as developing stability indicating assays. Our cGMP compliant facilities are equipped with state of the art technology to ensure rapid and accurate product characterisation and method development. This includes:

  • HPLC (UV/VIS, DAD, RI, FLD)
  • HPLC-MS
  • HPLC-MS/MS
  • UPLC (PDA, FLR)
  • Head space GC
  • Dissolution, DSC and Atomic Absorption Spectrometers
  • HPLC with DAD, RI, FLD (Agilent 1100, 1200 and 1260)
  • Ion chromatography
  • Laser diffraction particle size distribution
  • Automated dissolutions
  • Karl Fischer
  • FT-IR
  • Potentiometry
  • Pycnometry
  • TOC meter
  • Conductometry

We can also provide analytical validation in compliance with Ph. Eur, FDA, cGMP and ICH requirements.

For very advanced analytical development and problem solving we use our preclinical development lab where very highly qualified analytical chemists work with state of the art equipment (non- GMP) including:

  • NMR (up to 800 MHz)
  • HPLC/MS
  • HPLC/UV/VIS/Fluor.
  • HPLC/MS/MS
  • HPLC/UV/VIS
  • UPLC/Q-TOF (High resolution MS)
  • UPLC/MS/MC
  • GC/MS
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Compound Synthesis
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A range of synthetic chemistry services are available through our global development sites in Uppsala, Sweden and Ness Ziona, Israel.

Our repeated success in these endeavors is most definitely ascribed to the fact that over 75% of our in-lab staff hold a PhD degree with accompanying experience from a multitude of years in the... Show more »

A range of synthetic chemistry services are available through our global development sites in Uppsala, Sweden and Ness Ziona, Israel.

Our repeated success in these endeavors is most definitely ascribed to the fact that over 75% of our in-lab staff hold a PhD degree with accompanying experience from a multitude of years in the pharmaceutical industry.

In our well-equipped laboratories we can offer services ranging from advanced lead optimization medicinal chemistry, process development and tech transfer to large scale GMP-manufacturing. Other specialties include synthesis of bioconjugates (such as ADCs) and radiolabelling.

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Compound Manufacturing
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In Paderno Dugnano, Recipharm runs a multi-purpose plant which can manufacture several products at a time, handling high pressure, high temperature (up to 150 degrees Celsius) and low temperature (down to –80 degrees Celsius) reactions. Different batch sizes are available ranging from 20L to 6000L, supporting early development and... Show more »

In Paderno Dugnano, Recipharm runs a multi-purpose plant which can manufacture several products at a time, handling high pressure, high temperature (up to 150 degrees Celsius) and low temperature (down to –80 degrees Celsius) reactions. Different batch sizes are available ranging from 20L to 6000L, supporting early development and commercial needs. General APIs and some hormones are manufactured.

For exploratory work, optimisation and up-scaling of early syntheses, Recipharm’s development facility in Uppsala has an excellent track record in medicinal chemistry.

Recipharm also runs a dedicated beta lactam plant for the lyophilisation of bulk API in Lainate, Italy.

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Ophthalmic Formulation Development
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Recipharm’s site in Lisbon offers sterile manufacturing of eye and ear drops. The products are filled into plastic multi-dose containers.

In Kaysersberg, blow-fill-seal technology is used to provide customers with single use as well as multi-dose ophthalmic preparations.

Recipharm’s site in Lisbon offers sterile manufacturing of eye and ear drops. The products are filled into plastic multi-dose containers.

In Kaysersberg, blow-fill-seal technology is used to provide customers with single use as well as multi-dose ophthalmic preparations.

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Parenteral Manufacturing
Price on request

Recipharm has extensive experience in the injectables area and supplies small volume parenterals in ampoules and vials, as well as in cartridges. State of the art leak detection and automatic inspection equipment is used and Recipharm’s full service offering is complete with secondary packaging and temperature controlled... Show more »

Recipharm has extensive experience in the injectables area and supplies small volume parenterals in ampoules and vials, as well as in cartridges. State of the art leak detection and automatic inspection equipment is used and Recipharm’s full service offering is complete with secondary packaging and temperature controlled storage.

Lyophilisation

Recipharm offers state-of-the-art freeze drying processing with a lyophilisation area of more than 350 m2 for vials and ampoules. In the near future, this offering will be extended as Recipharm is expanding and building a modern, fully automated lyophilisation plant adjacent to the existing plant in Wasserburg, which will increase capacities by more than 50%. In a separate plant, an additional 160 m2 lyophilisation area is used for the freeze drying of beta lactams for dispatch in bulk containers. As part of Recipharm’s development services, freeze drying cycle optimization is offered.

Aseptic fill of sterile powder

Dry powder filling is performed in state of the art equipment. Dedicated facilities are available for penicillins and cephalosporins for worldwide supply. General APIs are filled in Recipharm’s WHO-certified facility in Paonta Sahib.

Focus on drug delivery

From a specialised polymer technology laboratory at the Pessac facility, development of pyrogen free drug carrying polymers for controlled release of injectable products is offered. This means customers have the opportunity to access a life cycle management or development service for new superior injectable formulations.

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Aerosol Manufacturing
Price on request

Recipharm is proud of its state of the art liquids manufacturing, offering liquids, sprays and aerosols in various containers. Organic solvents and propellants can be handled. With a broad range of equipment and compounding vessels from 100L to 5000L, it is possible to optimise the manufacturing process to meet customers’ needs.

Recipharm is proud of its state of the art liquids manufacturing, offering liquids, sprays and aerosols in various containers. Organic solvents and propellants can be handled. With a broad range of equipment and compounding vessels from 100L to 5000L, it is possible to optimise the manufacturing process to meet customers’ needs.

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Semisolid Manufacturing
Price on request

Recipharm is equipped to take on your semi-solid development and manufacturing project at one of four sites.

APIs

General APIs, as well as corticosteroids and controlled drugs, are handled within Recipharm's semi-solid dose manufacturing facilities.

Technologies

Recipharm manufactures creams, ointments, gels,... Show more »

Recipharm is equipped to take on your semi-solid development and manufacturing project at one of four sites.

APIs

General APIs, as well as corticosteroids and controlled drugs, are handled within Recipharm's semi-solid dose manufacturing facilities.

Technologies

Recipharm manufactures creams, ointments, gels, emulsions, aerosols and suppositories with conventional technology, including mixing with heating and vacuum. A unique topical patch manufacturing system is available for sustained drug release. Other products are filled in aluminum tubes, plastic tubes with long or short necks, syringes and aluminum cans, while suppositories are delivered in PVC or aluminum blisters. Creams can be processed using sterile manufacturing technology with aseptic filling into aluminum tubes. Separate terminal sterilisation is offered.

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Tablet Manufacturing
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With ten solid dose manufacturing sites, Recipharm has the capabilities to deliver your project from development through to the manufacture of large commercial batch sizes of tablets, capsules or powders. With significant experience in developing and manufacturing modified release products, our technology transfer teams can ensure... Show more »

With ten solid dose manufacturing sites, Recipharm has the capabilities to deliver your project from development through to the manufacture of large commercial batch sizes of tablets, capsules or powders. With significant experience in developing and manufacturing modified release products, our technology transfer teams can ensure smooth up-scaling and site transfers.

APIs

Recipharm handles general APIs as well as some special substances such as thyroid and sexual hormones, corticosteroids and controlled drugs. Beta lactams are handled in a dedicated facility.

Technologies

Solid dosage forms are manufactured with conventional technologies, including fluid bed granulation and water/organic solvents based coating. In addition, Recipharm has expert knowledge and a state of the art facility for manufacturing pellets with layering technology. Powder, crystals and pellets can be used as the starting material. The final pellets can be processed into tablets or filled into capsules or sachets, providing excellent means to fine tune the release profile of the finished product.

High performance, fully automated equipment for sachets allows Recipharm to deliver a competitive manufacturing service for large volume powder products, which is a particular area of expertise for the company.

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Chemistry and Materials
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Synthetic Chemistry
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Formulation Services
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Compound Sourcing and Management
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Compound Sourcing and Management Services

Compound Sourcing and Management Services

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Analytical Chemistry Services
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Manufacturing Services
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