We operate 8 API manufacturing sites (6 sites in India, one site in UK and one site in Mexico). Each of these sites has a dedicated purpose associated with capacity, capability, desired market and appropriate regulatory status.
Our capability footprint: 
Some key sites and operational capabilities are summarized below:
CTO-1
CTO-I is our dedicated state-of-the-art manufacturing plant where we produce Highly Potent APIs (HPAPIs). It is audited by the US FDA, MHRA, KFDA, and TGA. The warehouse is specially designed for handling highly potent raw materials in both solid and liquid forms. The facility has different dedicated modules for large and small batch sizes, with all prerequisites to handle high potent molecules. Our reactor capacity ranges from 5 L to 1000 L.
The facility also has special unit operations across all the modules ranging from material removal into the canister, layer separation, drying, rotation evaporator, and micronization. All modules have ANFD and micronizers in SS packing isolators. 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. We also offer special analytical services such as PSD, XRD, and microbiology.
CTO-3
CTO-3 is one of our key sites, intended for all phases of molecules. Apart from the regular chemistry, this site can handle Cryo reactions, Hydrogenations, Suzuki coupling reactions, and many other complex reactions. In addition to the 10-production block, CTO-3 is equipped with a GMP kilo lab which enables quick scale-up to support each phase of development. The facility also comes with state-of-the art QC labs, clean rooms, downstream operations such as filtration, drying, and multi mills. This facility is inspected by all major regulatory agencies such as the FDA, WHO GMP, MHRA, COFEPRIS, and KFDA.
CTO-5
CTO-5 is used typically for tonnage volume CMO projects. This site is equipped with 16 production blocks and 12 clean rooms. There are 150+ reactors of sizes ranging from 3kl to 10 kl and above and downstream unit operations such as filters, dryers, centrifuges, multi-mills, micronizers, and ATFDs operational on the site. This site is inspected by agencies such as the FDA, PMDA, EDQM, COFEPRIS, KFDA, and MHRA.
CTO-6
CTO-6 is one of our key sites operating in the Visakhapatnam cluster. This site manufactures intermediates, non-potent APIs, High Potent APIs (HPAPIs), and peptides. This facility has 12 production blocks and 18 clean rooms. This facility hosts a dedicated high-potent production block, QC, and warehousing. The peptide block is equipped with a PB-16 synthesizer and associated downstream equipment such as rotavapours, ion exchange resins and lyophilization. CTO 6 is audited by the US FDA, WHO GMP, PMDA, EMA, Health Canada, CFDA, COFEPRIS, and MHRA.
CTO-SEZ
CTO-SEZ is one of our most modern automated facilities where we manufacture Intermediates, non-potent APIs, High Potent APIs (HPAPIs), and peptides. This facility is equipped with a 100L capacity peptide synthesizer and associated downstream equipment like rotavapor, and ion exchange resins. The high potent block holds 7 reactors from 160L to 1 KL capacity ranges. The facility also can handle various unit operations such as ANFD, ATFD, fluid bed dryer, multi-mill, micronizers, lyophilizers, Tangential flow filtration (TFF). This facility is audited by various agencies such as the USFDA, MFDS, and Russian Federation.
Mexico Site
Located in Cuernavaca, Mexico, this facility has over 4 decades of experience in manufacturing steroidal APIs. Our Mexico facility is equipped with dedicated, and physically separated bays as well as dedicated HVAC systems for steroidal as well as non-steroidal API production. Our reaction volume in the steroidal area ranges from 30 to 1000 gallons. This site is audited by various agencies such as the US FDA, COFEPRIS, Russian Federation and KFDA.
Why Aurigene Pharmaceutical Services?
Plants across continents (India, UK and Mexico)
20+ years of legacy, 500+ molecules worked on, 15+ commercialized
Global regulatory inspections (such as the US FDA, PMDA, EDQM and MHRA)
cGMP scale from kg to MT
Wide range of technologies & niche reactions (peptide, steroid and high potent)
Wide range of unit operations
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Resources
APRIL 24, 2023
The importance of business continuity planning in CRDMO industry
Both natural and unnatural catastrophic events inflict negative consequences due to the ever-increasing interconnectedness of the global economy. Those consequences are certain to last for longer duration. e.g.; The Covid-19 pandemic is still having a negative impact on the global economy. Maintaining continuity is critical for all businesses, but perhaps no othe...
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Peptide Development and Manufacturing
Peptides are short chains of amino acids that are linked by peptide bonds. Several peptides linked together are called polypeptides. A protein contains one or more polypeptides. Therefore, proteins are long chains of amino acids held together by peptide bonds....
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Biologics Process Scale-up Services
Built on a solid platform of development and manufacturing scientist, we enable scale up doe both upstream and downstream processes. ...
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Designing a novel methodology for the development of a macrocyclic peptide molecule for both formulation development and pre-clinical studies
Background: An innovator company based in UK contacted us to support for the development of macro cyclic peptide molecule for pre-clinical studies. This peptide compound has been identified as potential candidate for the “Vaccination booster for elderly” under the therapeutic category of immunology. The synthesis of this compound posed many challenges such as...
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An efficient and convenient protocol for the synthesis of tetracyclic isoindolo[1,2-a]quinazoline derivatives
2016
A convenient and one-pot synthesis of tetracyclic isoindolo [1,2-a]quinazoline derivatives via Lewis acid mediated sequential C–N bond formation reactions is reported. This protocol provides a simple and rapid strategy for the synthesis of 12-benzylidene-10,12-dihydroisoindolo[1,2-b]quinazoline derivatives. However, a variety of tetracyclo indole fused quinazol...
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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2005
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 ...
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A Sensitive and a Simple RP-HPLC Method Development and Verification for the Quantitative Estimation of Cholecalciferolin Tablets
2005
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E)- 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formul...
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Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2005
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
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