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
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:
We take utmost care in handling highly potent materials at every stage of the manufacturing journey.
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.
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.
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
JANUARY 04, 2021
Physicochemical properties of drug forecast its ADME chance, however, the formulation development strategy or dosage form is decided based on the bioavailability, commencement and duration of therapeutic response. An ideal strategy for formulation development should consider the dose of the drug, intended route of administration, anatomical and physiological barr...Read More
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....Read More
Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...Read More
The reaction of b-chloroacrolein with 1 equiv of 2-aminophenol in DMF proceeds smoothly to afford 11-hydroxy derivative of chromenoquinoline in good yield. This single pot method allows for a rapid access to a variety of chromenoquinolines or oxepinoquinolines depending on the nature of b-chloroacrolein used. The structures were established by spectroscopic data ...Read More
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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 ...Read More
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