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Why Selection of a Contract Manufacturing Organization (CMO) for HPAPI Development is Necessary? Highly potent active pharmaceutical ingredients (HPAPIs) are the compounds used extensively today for the treatment of respiratory disorders, cancer and hormonal imbalances. The key factors driving the demand for highly potent active pharmaceutical ingredients (HPAPIs) are the rise in the oncology therapeutics market as well as the surge in the need for better medicines for treating Cardiovascular, C

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AMRI

AbbVie Contract Manufacturing

Aesica Pharmaceuticals Limited

Arevipharma GmbH

Ash Stevens, Inc.

CARBOGEN AMCIS AG

Cambrex Corporation

Cerbios-Pharma SA

ChemCon GmbH

DOTTIKON EXCLUSIVE SYNTHESIS AG

Dishman Carbogen Amcis

Evotec

Farmhispania, S.A.

Fermion Oy

Fresenius Kabi Austria

Indena

Mac-Chem Products (India) Pvt.Ltd

Magle Chemoswed

Medichem S.A

Minakem

Olon Spa

PROCOS S.p.A.

Pfanstiehl

Pfizer CentreOne

Piramal Pharma Solutions

ScinoPharm Taiwan, Ltd

Servier

Siegfried AG

Stason Pharmaceuticals, Inc.

Wavelength Pharmaceuticals

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Virtual BoothWorld-Class Developer & Manufacturer of Differentiated APIs// in 50 countries// 198 DMFs Worldwide.

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Wavelength Pharmaceuticals offers contract manufacturing services for the production of highly potent active pharmaceutical ingredients (HPAPIs) / highly potent drug substances along with steroids and cytotoxic compounds.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

Virtual BoothPfizer CentreOne™ is a global CDMO and a leading supplier of specialty APIs.

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Pfizer offers manufacturing expertise for potent drugs, liquid cytotoxics, biologics, small molecules, controlled substances (II-IV), liposomal, inactivated vaccines, monobactam, sterile suspensions, hormones, steroids & prostaglandins.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

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Minakem offers a state-of-the-art high containment manufacturing facility to handle high potent APIs (HPAPIs) from early-stage development to scale-up & commercial manufacturing.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

Virtual BoothGeneric APIs,HPAPIs & FDFs/ Chlorhexidine/ CMO for branded & generic products/ 339 DMFs/ 15 CEP/ 866 MAs

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Manufacturing capabilities from our API plant in Malta. We produce Class 4 HPAPIs with OEL down to 40 ng/m³ within cGMP and FDA inspected environments.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

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AMRI’s experts bring more than 25 years of experience in the production of cytotoxic and other highly potent compounds, from grams to tens of kilograms per year to take the high-potency compound from discovery through manufacturing and into the clinic.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

Virtual BoothA leading process R&D and API Manufacturing service provider to the Global Pharmaceutical Industry.

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ScinoPharm provides one-stop-shop service for our existing API customers. The company also adopts Double A (API+ANDA) business model to team up with Pharma companies to apply for ANDA in US/EU and export final drug products globally.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

Virtual BoothBegin the journey of your innovative API with Fermion.

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Fermion offers contract manufacturing for HPAPIs, APIs & advanced intermediates with best-in-class facilities and high level of automation. It also offers cost-efficient synthesis, process development & life-cycle management solutions.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

Virtual BoothWe work with global companies to develop, manufacture & scale biopharmaceutical products.

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AbbVie Contract Manufacturing has high potency manufacturing capabilities. They efficiently handle high potency drugs, from pilot scale (1 kg to 100 kg) through to clinical trials and large-scale commercial production.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

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20 years of experience in handling HPAIs according to cGMP, Cerbios is highly qualified in process development and manufacturing of New Chemical Entities with High Potency (High Potency Active Ingredients) characteristics from preclinical to commercial.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

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To handle active substances, DOTTIKON has state-of-the-art containment concepts on all scales (e.g. closed charging/handling/discharging, full protection suit, monitoring, WIP/CIP cleaning, and cleaning validation). These concepts are applied by highly sk

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

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We perform multi-step synthesis and are experts in handling high potent compounds. cGMP standards are applicable also at this scale.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

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Mac-Chem has state-of-the art cat III & IV containment facility with isolators / glove box technology for manufacturing & handling of highly potent cytotoxic pharmaceutical substances.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

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high-potent APIs, a special pharma lab was commissioned in 2008 in order to develop and manufacture pharmaceuticals with APIs up to an OEL level of 4.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

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Ash Stevens is a leader in the development and cGMP manufacture of high potency active pharmaceutical ingredients (HPAPIs).

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

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The Dishman Group offers unparalleled capability in scale-up, development and commercial manufacture of highly potent APIS and vitamins. All our facilities operate under cGMP.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview