• search
CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
High Potent API Manufacturing Services

High Potent API Manufacturing Services

Partner of choice for safe High Potent API manufacturing

  • Legacy of having manufactured 50+ high potent compounds
  • One of the largest infrastructures 3+ cytotoxic site, 1 steroid site and 1 prostaglandin site

We have one of the largest capacities in the world to manufacture highly potent compounds with Occupational Exposure Limit (OEL) in the range of 0.1-1 μg/m3 (OEB 5). Our facilities are audited by US FDA and regulatory bodies.

We offer manufacturing of high potent compounds supported by special unit operations like micronization and spray drying. Our facility is designed to give output as low as 100 gm to multi-tons.

Our approach for high potent handling pharmacokinetic Studies

Speak to our experts

Overview of our High Potent Sites and Features:

We provide high potent API manufacturing services from 3 sites based out of India. All sites are inspected by US FDA and other reputed regulatory bodies. Some of the key features of sites are as listed below:

  • Multipurpose facility with various sized reactors
  • Isolator technology in place for containment to handle OEB 5 compounds
  • Hastelloy ANFD with isolators
  • Facility for milling, blending and packing under isolation techniques with isolators
  • Analytical instruments (HPLCs, GC, FTIR, UV-Vis, polarimeter and microbiology laboratory)
  • Cleaning-in-place (CIP) practiced under the closed condition
  • Separate effluent detoxification reactor

Material Handling

We take utmost care in handling highly potent materials at every stage of the manufacturing journey.

  • cGMP compliant isolator systems (OEL 0.1µg/m³) for highly potent raw materials, intermediates dispensing, charging, filtration and drying, and packaging
  • Reaction mass transfer through closed loop lines
  • Rapid transfer ports for solid material transfer
  • Dedicated warehousing: The warehouse is specially designed for handling high potent raw materials in both solid and liquid forms. A SAP-integrated barcode system logs proper storage

HVAC and Utilities

  • HVAC system with zone classification to avoid cross-contamination
  • Differential pressure system with temperature and humidity control
  • HEPA filtered air
  • Multiple utilities (cooling tower water, hot water, chilled brine, nitrogen, compressed air and steam)

Production Blocks and Unit Operations

The manufacturing process starts with reaction, sampling, workup, and isolation, followed by filtration and drying operations. The facility also has special unit operations across all the modules ranging from material removal into the canister, layer separation, drying, rotation evaporator, spray drying, and micronization. All modules have ANFD and micronizers in SS packing isolators.

Dedicated QC

All the analysis steps, such as in-process, intermediate, and complete, are performed in a dedicated QC lab designed to handle high potent molecules. The QC lab is equipped with a weighing and sample preparation isolator. The samples are analyzed using various equipment such as HPLC or GC. The QC lab relates to Empower 3 servers and all the data related to in-process, intermediate, and complete analysis steps are transferred to SAP through LIMS software.


Our manufacturing processes follow not only the highest quality but also sustainability standards to protect the environment and our workforce. The effluents are treated and processed in detoxifying areas, as per regulatory standards.

Why Aurigene Pharmaceutical Services?

One of the largest capacities in Asia- 3 US FDA inspected cytotoxic GMP facilities

Variety of unit operations in containment

Highest standards of safety

Experience in manufacturing 50+ high potent compounds

Dedicated high potent R&D facility allowing for faster development and technology transfer

Virtual Tour


Contact Us

CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

JUNE 28, 2022

Neoantigen Specific T cells For Cancer Immunotherapy

Neoantigen specific T cells for cellular cancer immunotherapy An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence...

Read More

Building successful long-term partnerships with CDMOs from early drug discovery through commercialization

Building successful long-term partnerships with CDMOs from early drug discovery through commercialization Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contr...

Read More

Technology meets sustainability - How a complex API development process goes green

We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...

Read More

Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug


Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...

Read More
View All

You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.

If you wish to continue to this external website, click Proceed.