High Potency API (HPAPI) | Contract Manufacturing

Seqens is a contract development and manufacturing organization that offers highly potent and oncology APIs with OEB 4 and 5 (1µg/m3) levels. It is involved in the production of clinical and lab to full commercial scales of potent molecules.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

02

Minakem

France

DCAT Week

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

Pharma Service : API Manufacturing

Minakem offers state-of-the-art high containment manufacturing facility for highly potent APIs from early-stage development to scale-up and commercial manufacturing. It can handle HPAPIs with OEL below 0.1μg/m³/shift (OEB class 5).

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

03

Gentec Pharmaceutical Group

Spain

CPhI WW Frankfurt

Booth #11.1C90

Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

Pharma Service : API Manufacturing

Gentec's Duke Chem and Pharmanoid plant offers manufacturing services for high potency active pharmaceutical ingredients (HPAPIs) and APIs under the contract manufacturing modality.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

04

TAPI Technology & API Services

Israel

World ADC London

TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

Pharma Service : API Manufacturing

TAPI is a CDMO for high potent APIs (HPAPIs), supporting its R&D through commercial manufacturing with reactor sizes ranging from less than 100 liters to 7,000 liters.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

05

Polpharma

Poland

DCAT Week

Polpharma API is a contract development and manufacturing organization (CDMO) specializing in the manufacturing of high-potency APIs (HPAPIs) in its dedicated GMP kilo-labs, with an occupational exposure limit (OEL) as low as 10ng/m3 (OEB 6).

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

Pharma Service : API Manufacturing

HPAPI MANUFACTURING

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

06

Axplora

Germany

INS 2025

Not Confirmed

Axplora- The partner of choice for complex APIs.

Pharma Service : API Manufacturing

Axplora offers a full range of high-potency API (HPAPI) manufacturing services. It also has great expertise in the development, scale-up, and handling of cytotoxics and highly active compounds with an OEL below 10 ng/m³.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

MANUFACTURING OF HIGHLY POTENT APIs (HPA...

07

AbbVie Contract Manufacturing

U.S.A

INS 2025

Not Confirmed

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

Pharma Service : API Manufacturing

AbbVie CMO has the capability of producing HPAPI with containment capabilities up to OEB5 (<0.1 µg/m3). Its Campoverde and Sligo sites have over 20 years of experience and can support a broad range of commercial GMP batch sizes from gram scale to 600 kg.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

Manufacturing of Highly Potent APIs (HPAPIs)

08

Veranova

U.S.A

INS 2025

Not Confirmed

Veranova: A CDMO that manages complexity with confidence.

Pharma Service : API Manufacturing

With an increasing number of new drugs under development containing highly potent APIs (HPAPIs), Veranova is able to combine its extensive technical expertise with specialized equipment to produce HPAPIs (SafeBridge®4) with OEL as low as 1 μg/m3.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

09

Aspen API

Netherlands

Tides Asia

Aspen API strengths lie in manufacturing APIs at various production scales with a specialization in HPAPIs. The chemical capabilities offer containment capability for manufacturing and handling HPAPI products from OEL 1 ug/m³ to 50 ng/m³.

Aspen API. More than just an API.

Pharma Service : API Manufacturing

HIGHLY POTENT API MANUFACTURING

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

10

Evonik

Germany

ESF Europe

Evonik is the world’s largest contract manufacturing organization with more than 20 years of expertise in high-potency APIs. It has a total HPAPI capacity of 170m³, with reactors up to 7,600 liters in capacity.

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Pharma Service : API Manufacturing

CMO FOR HIGH POTENCY APIs (HPAPIs)

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

HPAPI CONTRACT MANUFACTURING SERVICES

11

Fermion Oy

Finland

INS 2025

Not Confirmed

With Fermion, start the journey of your innovative API.

Pharma Service : API Manufacturing

Fermion is a CDMO with manufacturing expertise in highly potent APIs, high-quality cytotoxics with three fully automated HPAPI modules for OEB5 (0,1 - 1 µg/m3) classified APIs with reactors of 250 L, 400 L and 600 L.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

12

Cohance Lifesciences

India

INS 2025

Not Confirmed

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Pharma Service : API Manufacturing

Cohance Lifesciences has state-of-the-art contract manufacturing facilities for the high potency APIs. It is a CDMO that can handle the development and production of HPAPIs including cytotoxic and oncology APIs with OEB 5 classification.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

13

Egis Pharmaceuticals PLC

Hungary

PharmaVenue

Egis Pharmaceuticals has GMP production lines that can handle 1 g/m3 < OEL < 10 g/m3 (OEB4) levels of highly potent APIs. It also produces HPAPIs for formulation experiments, clinical trials, and commercial purposes with an annual capacity of ca. 600 kg.

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Pharma Service : API Manufacturing

HIGHLY POTENT API MANUFACTURING

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

Malladi has specialized facilities and systems for high potency active pharmaceutical ingredients (HPAPIs). Its facilities can support manufacturing volumes ranging from a kilo to multi-ton levels.

14

Malladi Drugs & Pharmaceuticals Limited

India

INS 2025

Not Confirmed

Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

Pharma Service : API Manufacturing

HPAPI MANUFACTURING SERVICES

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

15

Aarti Pharmalabs

India

INS 2025

Not Confirmed

Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

Pharma Service : API Manufacturing

Aarti Pharmalabs is a leading CDMO that offers contract development and manufacturing (CDMO) services for various drug substances such as high-potency active pharmaceutical ingredients (HPAPIs), including anti-cancer and cytotoxic compounds.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

CONTRACT MANUFACTURING FOR HIGH POTENCY ...

16

Ami Lifesciences Private Limited

India

INS 2025

Not Confirmed

AMI Lifesciences is Driven by Chemistry. Powered by People.

Pharma Service : API Manufacturing

Ami Lifesciences is involved in the contract development and manufacturing of high potency APIs. It offers end-to-end services from small-scale to commercial manufacturing of HPAPIs and small molecules.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

Contract Manufacturing for High Potency APIs

Aurigene Pharmaceutical Services is a CDMO that provides highly potent API manufacturing services. It has cGMP isolator systems that can handle the manufacturing of HPAPIs, highly potent raw materials & intermediates in the range of 0.1-1 μg/m3 (OEB 5).

17

Aurigene Pharmaceutical Services

India

DCAT Week

Lotte New York Palace

Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

Pharma Service : API Manufacturing

HPAPI MANUFACTURING SERVICES

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

18

Medichem S.A

Spain

INS 2025

Not Confirmed

Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

Pharma Service : API Manufacturing

Medichem produces Class 4 HPAPIs with OEL down to 40 ng/mÂ³ in its state-of-the-art cGMP facilities.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

CONTRACT MANUFACTURING FOR LIQUID CYTOTO...

19

Pfizer CentreOne

U.S.A

INS 2025

Not Confirmed

Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

Pharma Service : API Manufacturing

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

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

Contract Manufacturing for Liquid Cytotoxics

20

Farmhispania

Spain

INS 2025

Not Confirmed

Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.

Pharma Service : API Manufacturing

Farmhispania is a leading European contract development and manufacturing organization (CDMO) for high potency APIs. It offers cGMP manufacturing of HPAPIs including cytotoxics with an OEL below 30 ng/m3, from a few small grams to multi kilograms.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

Porton Pharma is a contract development and manufacturing organization (CDMO) that has a high potency lab (<0.05 ug/m³) for handling the production of highly potent APIs.

21

Porton Pharma Solutions

China

INS 2025

Not Confirmed

Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

Pharma Service : API Manufacturing

HIGHLY POTENT API MANUFACTURING

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

22

Pfanstiehl

U.S.A

INS 2025

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Pharma Service : API Manufacturing

Pfanstiehl is a CDMO that is involved in the development and manufacturing of HPAPIs. It is equipped with large-scale high potency manufacturing with class 100,000 / SafeBridge Category 1-3 production facility with an OEL range from 0.03 to 5 μg/m³.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

MANUFACTURING OF HIGHLY POTENT APIs (HPA...

23

Bioquim

Spain

INS 2025

Not Confirmed

Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.

Pharma Service : API Manufacturing

With expertise in sterile lyophilization and chemical synthesis, Bioquim CDMO offers the production of a wide range of cGMP oral and sterile APIs including high potency APIs (HPAPIs) for human and veterinary markets.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing