We offer a wide range of formulation development services, from preclinical formulation to developing and manufacturing first-in-human clinical supplies to commercial supplies. We have expertise in developing all major dosage forms including oral solids, parenteral and topical dosage forms.
Our commercial manufacturing facilities mainly cover potent and non-potent oral solids, oral liquids, topicals, nasal sprays and soft gelatin capsules . Our manufacturing facilities are audited by major regulatory agencies. 
Pre-formulation
Our preformulation studies cover the assessment of a wide range of physical and chemical properties, which are critical to design the formulation and delivery method for your lead candidates. Once the drug properties are studied, our team of experts can help arrive at the right formulation that meets the necessary regulatory guidelines.
Early-phase Formulation
Our early-phase formulation development services help solve oral bioavailability challenges encountered at both preclinical formulation development and clinical formulation development stages. We can address following issues through in-depth solubilization and enabling various technologies:
- Incomplete dissolution
- Low solubility
- Low oral bioavailability
Our services for discovery phase formulation development are tailored to address specific challenges which arise due to:
- Higher systemic exposure requirements for toxicology studies
- Non-feasibility of high doses or strengths
- Studies in varied animal species
- Emesis
- Compound limitation
- Liquid dosage form requirement
- Precipitation of compound at absorption site
Formulation Development
We offer formulation development services from GLP-compliant and cGMP environment to meet client requirements. Our formulation development services can help in translating new drug candidates into drug products for your clinical trial needs.
Our formulation development services include:
- Preclinical (Oral- Solution, suspensions and microdose capsules, Parenterals- aqueous liquid injectables, non-aqueous injectables, lyophilized injectables, ophthalmic and otic solutions and nasal solutions)
- First in human formulations (Oral Solids, Parenterals)
- Clinical formulations (Oral solids, soft gelatin capsules and parenterals-aqueous liquid injectables, non-aqueous injectables, lyophilized injectables, ophthalmic and otic solutions and nasal solutions)
Characterization Studies
We conduct all characterization studies in-house. Dissolution testing is a requirement for solid oral dosage forms throughout the development life cycle and commercial manufacturing. Our services help understand the process in which a substance forms a solution and measure the extent and rate of solution formation from a dosage form, such as a tablet, capsule, and ointment.
Our characterization services for NCEs, generics and first generics help assess the quality characteristics of drug products such as physical and chemical properties, which are primary elements to ensure the desired quality, considering the safety and efficacy of the drug product.
We help to understand physical, chemical, biological, and microbiological properties or characteristics that should be within an appropriate specification to ensure the desired product quality.
The potential physical and chemical interactions between drugs and excipients can affect the dosage form's chemical, physical, and therapeutic properties, and stability. Drug excipient compatibility studies are an important part of understanding the role of inactive ingredients (excipients) in product quality and performance. Our mechanistic understanding of the drug substance and its impurities, excipients, and impurities, degradation pathway, and potential processing conditions helps select the right excipients for the compatibility study.
Pharmaceutical Stability Studies
We help our clients understand the stability and quality of drug substances (API) and drug products (finished formulation) against different environmental factors such as temperature, humidity, and light. Our stability testing services are offered by ICH guidelines. They include the study of product-related factors that influence the quality of a drug, such as the interaction of an API with excipients, container closure systems, and packaging materials but also the proneness to oxidation and hydrolysis.
Clinical Supplies
We manufacture clinical formulations from our USFDA-inspected sites based out of Hyderabad and Visakhapatnam, India. We can cater to manufacture oral solids as well as soft gelatin formulations.
Why Aurigene Pharmaceutical Services?
Services from early formulation to clinical manufacturing
Integrated API and formulation capabilities
Experience with advanced formulation technologies
Integration with biology services for in vitro and in vivo studies
Global accreditations
Other Services
- Clinical and Pharma Commercial Packaging Services
- Clinical Supplies and Pharma Commercial Manufacturing Services
- CMC and Pharma Regulatory Support Services
- Dosage Formulations Development Services
- Drug Product Characterization Studies and Testing Services
Clinical and Pharma Commercial Packaging Services
Clinical Supplies and Pharma Commercial Manufacturing Services
CMC and Pharma Regulatory Support Services
Dosage Formulations Development Services
Drug Product Characterization Studies and Testing Services
Drug Product Formulation Development Services
Early Phase Formulation Development Services
Formulation Studies and Services
Integrated Drug Substance and Drug Product (DS-DP) Services
Pharmaceutical Stability Studies and Services
Preformulation Studies and Services
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Drug Formulation Services
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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Accelerating Drug Discovery Through Innovative Partnerships
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....
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Biologics Process Development Services
Our strength is built on a deep understanding of cell culture, protein chemistry and an integrated analytics platform enabling a robust, scalable and controlled process. ...
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Developing a methodology for In situ perfusion based combined tissue distribution and toxicity evaluation study
Challenges: Several repeated in house validation studies were performed to optimize the suitable perfusate (liquid medium intended to pass through the heart), perfusate volume and perfusion rate to ensure complete perfusion of animal subjects (parameters weren’t adjustable) Challenges were encountered in adjusting the perfusion volume and rate vis-à-vis ensuri...
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Cu-catalyzed coupling-cyclization in PEG 400 under ultrasound: a highly selective and greener approach towards isocoumarins
2013
The combination of CuI–K2CO3-PEG 400 facilitated the couplingcyclization of o-iodobenzoic acid with terminal alkynes under ultrasound, affording a greener and practical approach towards 3-substituted isocoumarins with remarkable regioselectivity. This inexpensive and Pd and ligand free methodology gave rise to various isocoumarins of potential pharmacological i...
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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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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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Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2005
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...
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