HPAPI Development | High Potency API I Complex APIs

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

Pharma Service : API & Drug Product Development

Minakem is a CDMO that offers contract development and manufacturing solutions for the synthesis of HPAPIs (Highly Potent Active Pharmaceutical Ingredients) and intermediates at all production scales.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

02

Aurigene Pharmaceutical Services

India

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

Pharma Service : API & Drug Product Development

Aurigene Pharmaceutical Services is a CDMO that offers safe, scalable, and phase appropriate solutions for high potency APIs. It provides highly potent small molecule development services for API and intermediates with OEL of 0.1µg/m³.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

Aurigene Pharmaceutical Services HPAPI Development Services

DEVELOPMENT OF HIGH POTENCY APIs (HPAPIs...

03

Evonik

Germany

Pharmtech & Ingredients

Not Confirmed

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

Pharma Service : API & Drug Product Development

Evonik is the industry’s largest HPAPI process developer and manufacturer for more than 20 years with a total reactor capacity of 170m³. It has a cGMP suite for the small-scale production of HPAPI and ultra-HPAPI.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

Development of High Potency APIs (HPAPIs)

04

Axplora

Germany

BOS Manchester

Axplora- The partner of choice for complex APIs.

Pharma Service : API & Drug Product Development

Axplora is a CDMO that offers high-potency API development services. Its Le Mans site located in France, and Gropello site in Italy, offer process development and cGMP production of highly potent APIs (HPAPIs) and cytotoxic APIs.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

Polpharma API is a CDMO that has a highly specialized area for the development and manufacturing of high-potency APIs (HPAPIs). It has a new greenfield R&D and production facility dedicated to HPAPI products with OEL 1-10 µg/m3.

05

Polpharma

Poland

Pharmtech & Ingredients

Not Confirmed

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

Pharma Service : API & Drug Product Development

HPAPI DEVELOPMENT & MANUFACTURING

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

HIGHLY POTENT API DEVELOPMENT SERVICES

06

Veranova

U.S.A

BOS Manchester

Exhibiting

Veranova: A CDMO that manages complexity with confidence.

Pharma Service : API & Drug Product Development

Veranova combines its extensive technical expertise with specialized equipment for the development and production of highly potent active pharmaceutical ingredients (SafeBridge®4).

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

Veranova Highly Potent API Development Services

07

Aspen API

Netherlands

DEVELOPMENT OF HIGH POTENCY APIs (HPAPIs...

Aspen API. More than just an API.

Pharma Service : API & Drug Product Development

Aspen API is a CDMO offering development and up-scaling of complex high potency APIs (HPAPIs). It offers containment capabilities for manufacturing and handling HPAPI products from OEL 1 ug/m³ to 50 ng/m³.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

08

Fermion Oy

Finland

Fermion's R&D laboratory contains 55 fume hoods & has special laboratory spaces for hydrogenation & highly potent APIs (HPAPI). Fermion’s Oulu site focuses on smaller volume highly potent OEB5 APIs from a scale of 1-2kg per batch to one metric ton.

With Fermion, start the journey of your innovative API.

Pharma Service : API & Drug Product Development

DEVELOPMENT OF HIGHLY POTENT APIs

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

09

Seqens

France

Pharmtech & Ingredients

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Pharma Service : API & Drug Product Development

Seqens offers custom drug substance development services, including HPAPI containment down to 100 ng/m3. It has the capability to develop APIs with a high level of confinement up to OEB 4 and OEB 5.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

10

Cohance Lifesciences

India

Cohance Lifesciences offers end-to-end CDMO services for the development of high potency APIs. It has OEB 5 containment capabilities that can handle the development of HPAPIs including cytotoxic and oncology active pharmaceutical ingredients.

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

Pharma Service : API & Drug Product Development

HPAPI CDMO SERVICES

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

11

Egis Pharmaceuticals PLC

Hungary

CDMO FOR HIGHLY POTENT DRUG SUBSTANCES

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

Pharma Service : API & Drug Product Development

Egis Pharmaceuticals has cutting-edge infrastructure for the contract development of traditional and highly potent (HP) drug substances. It involves the synthesis and scale-up to a maximum 15 L volume with OEB4 classification 1 g/m3 < OEL < 10 g/m3.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

12

Fareva

Luxembourg

BOS Manchester

Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

Pharma Service : API & Drug Product Development

Fareva has more than three decades of experience in the development and manufacturing of active ingredients and pharmaceutical products. Its API range includes highly potent (HPAPIs), sterile, controlled substances, and cytotoxics.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

13

Gentec Pharmaceutical Group

Spain

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

Pharma Service : API & Drug Product Development

Gentec's Pharmanoid plant is dedicated to the development of HPAPIs including several prostaglandins for ophthalmic use. It has facilities which are certified for cGMP compliance that allow the handling of HPAPIs with containment.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

14

Aarti Pharmalabs

India

Booth #2.F08

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

Pharma Service : API & Drug Product Development

Aarti Pharmalabs is a leading CDMO that offers contract development and manufacturing services for various drug substances such as HPAPIs, including anti-cancer and cytotoxic compounds, along with steroid APIs.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

15

Ami Lifesciences Private Limited

India

Booth #1.C02

AMI Lifesciences is Driven by Chemistry. Powered by People.

Pharma Service : API & Drug Product Development

Ami Lifesciences is a CDMO that offers development and manufacturing services for the exclusive synthesis of HPAPIs (highly potent active pharmaceutical ingredients), small molecule APIs, and large molecule APIs.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

CDMO FOR HIGHLY POTENT APIs (HPAPIs)

16

Farmhispania

Spain

Pharmtech & Ingredients

Not Confirmed

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

Pharma Service : API & Drug Product Development

Farmhispania has facilities for the development, scale up, and cGMP manufacturing of HPAPIs such as cytotoxics with an OEL below 30 ng/m3, from a few small g to multi kg. It specializes in highly potent API technology including HPAPI fermentation.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

17

Porton Pharma Solutions

China

Pharmtech & Ingredients

Not Confirmed

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

Pharma Service : API & Drug Product Development

Porton Pharmas' API Process Development Center in Chongqing, China has a high potency lab (<0.05 ug/m³) that is involved in the contract development and manufacturing of highly potent APIs (HPAPIs).

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

18

Pfanstiehl

U.S.A

Pharmtech & Ingredients

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 & Drug Product Development

Pfanstiehl is engaged in the contract development and manufacturing of high potency APIs (HPAPIs) with an OEL range of 0.03 to 5 μg/m³.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

With more than 40 years of experience in sterile lyophilization and chemical synthesis, Bioquim CDMO offers a comprehensive range of cGMP oral and sterile products, including HPAPIs for human and veterinary markets.

19

Bioquim

Spain

Pharmtech & Ingredients

Not Confirmed

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

Pharma Service : API & Drug Product Development

CDMO FOR HIGH POTENCY APIs (HPAPIs)

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development