Formulation services
Early stage development to commercial
manufacturing.
16
USFDA inspected
cGMP facilities
3
manufacturing countries
UK, Mexico, India
Explore our wide range of formulation development services
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.
- Toxicology
formulations- Pre - formulation studies
- Preclinical formulation for PK studies
- TOX formulation for development & preparation for dosing
- Solubility and Bioavailability enhancement
- FIH and Clinical
formulations- Dosage form selection
- Formulation development
- Process development
- Solubility and Bioavailability enhancement
- Clinical supplies for PK, SAD, MAD & Food effect studies
- Clinical
formulations- Formulation development
- Process development
- Formula and process optimization
- Clinical supplies for Phase lla,IIb & phase III studies
- Commercial
formulations- Scale-up & technology transfer
- Process validation & product commercialization
- Product registration and regulatory documentation support.
Our dosage formulations offering
Starting with comprehensive pre-formulation services to commercial manufacturing, we provide a full suite of services for formulations of oral, parenteral and topical dosage forms. We offer “Fit-for-purpose” formulation development for pre-clinical and First in Human (FIH) studies based on molecules’ physico-chemical behavior, excipient compatibility studies, and quick screening of excipients.
We are equipped with state-of-the-art facilities to manufacture 500 to 50,000 units at R&D and up to 7,500,000 units at commercial manufacturing sites and complete CMC support for regulatory submission.
Cross-functional teams such as DMPK, API synthesis, salt screening, toxicology, process engineering, analytical development and regulatory teams are located in the same campus and work in an integrated manner at each stage of the life cycle of the molecule for efficient and on-time delivery.
Oral solid
dosage
Liquid
oral dosage
Topical
dosage
US FDA
inspected
Ophthalmic
and otic dosage
Nasal
dosage
Why Aurigene Pharmaceutical Services?
20+
years’ experience
900+
scientists
125+
global clients
600+
projects
19
NCEs
commercialized
16
USFDA inspected
cGMP facilities
6
Biologics
commercialized
3
manufacturing countries
UK, Mexico, India
Our Infrastructure
R and D centers
Aurigene Pharmaceutical Services is well-equipped with laboratories from discovery to clinical phase III for NCEs and NBEs. We operate two state-of-the-art R and D centers in Bangalore and Hyderabad. Our R and D centers are equipped with 60+ modular laboratories to handle highly potent substances, peptides, oligonucleotides etc. Our facility also has an extensive analytical center of excellence in addition to special purpose labs for safety assessment studies and polymorphism studies. Our best-in-class discovery biology services are supported by AAALAC accredited vivarium, BSL-2 compliant labs, in vivo facilities, GLP and other regulatory bodies accredited toxicology labs. Our state-of-the-art preclinical evaluation safety facility has been inspected by FCPSA Netherlands, DCGI and is annually inspected by National GLP Compliance Monitoring Authority (NGCMA). Our facility has also been inspected by the US FDA and the quality systems in this facility are in accordance with NGCMA and US FDA standards.
Manufacturing facilities
We have access to cGMP manufacturing facilities in the UK, Mexico and India. We operate thousands of kilo liters of API capacities that can handle various range of chemistries from regular small molecules, peptides, potent compounds, steroids, carbohydrates and pegylated drugs. In addition, we also operate formulation manufacturing plants that can handle various dosage forms including oral solids, parenteral and topical. Our facilities are designed modularly and offer flexibility of scale, enabling efficient operations. Our manufacturing facilities are regularly inspected by regulatory agencies.
Our commitment to ESG Goals
Aurigene as a wholly owned subsidiary of Dr. Reddy’s Laboratories adopts the ESG goals of our parent company. Dr.Reddy’s has been committed to sustainability, diversity and equality for over two decades and has been honored with numerous accreditations and awards.
Awarded ‘Gold Medal’ status by EcoVadis, the global sustainability ratings agency, 2023
First Indian pharma firm to earn a place in the Standard & Poor Dow Jones Sustainability World Index (DJSI World) for 2023.
6th year in a row to be featured in the Bloomberg Gender-Equality Index (GEI) 2023.
Achieved “A” rating for supplier engagement, and for climate change & water security in 2023 by Carbon Disclosure Project (CDP)
Accelerate your molecule to market
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