CORE ACTIVITIES
1
To develop robust and scalable processes for APIs, Intermediates & Specialty product with the highest grade of quality.
2
Developing non-infringing processes & Identifying & exploring patent-fencing opportunities to create IP assets for API & Intermedites.
3
All respective analytical activities are inline with regulatory guidelines OR as per customer requirements
4
Technology transfer of the new processes to Validation scale.
5
Technical Package of new processes and technology having detailed information.
6
Technical reply to queries from EDQM/USDMF/Customer
7
Technical Support to the marketing department and various customers.
8
Complete support for filing DMF (US-DMF, CEP, Canada and Australia and other regulatory bodies). Support to Regulatory Affairs & Quality Assurance for all R&D related activities.
9
Identification and isolation of Genotoxic/non-genotoxic impurities in process and method development (TTC approach) to define systematic control measures.
10
Detailed impurity profiling during development and accordingly in-house synthesis of all necessary Impurities and its characterization
ADL – CORE ACTIVITIES
Analytical method development and validations
- Key starting materials, in-process, intermediate,
- API and cleaning samples.
- Carry-over of Potential genotoxic impurities and mutagenic substances.
- Nitrosamine impurities
- Impurity fate mapping & Theoretical purge factor (TPF) determining
- Verification of pharmacopoeial analytical methods
- Method equivalence study for in-house vs compendial methods
Stress / Forced degradation Studies - API
- Under thermal, photolytic and humidity
- Under acidic / basic / oxidization conditions
Indicative Stability Study - API
- At different storage conditions with various temperatures and humidity
- At different packaging conditions
Reference Standard Management
- Qualification of reference and working reference standards using HPLC / GC / TGA analysis
- Characterization of reference and working reference standards using IR / MS / NMR studies
Impurities Identification & Isolation
- Identification of impurities using IR / LC-MS / GC-MS / NMR techniques
- Isolation of impurities using preparative HPLC, followed by qualification and characterization
GUIDELINE
GLP/GDP Compliant: GLP-Good laboratory compliant as well as GDP-Good documentation Compliant
Conforming to Global Guidelines
- ICH Guidelines
- USP Guidelines
- European Guidelines
- FDA Guidelines
- WHO Guidelines
- In-house SOP Guidelines
Labs
0
PhDs
0
+
sqft Builtup Area
0
K
R&D capacity is our Advantage
- Chieron supports our existing and future customers through nine world-class research & analytical laboratories for supporting new product development.
- We have modern instrumentation, computer systems , safety equipment and database access. It features lab centrifuges, weighing balances, hot air sources and vacuum ovens.
- There is a separate area dedicated to development of high pressure reactions.
- Additionally, pilot plant is conveniently located on the same site.
- Our customers have benefitted through.
- Telescopic processes that reduce product losses & improve the scalability of products
- Process intensification that improves the efficiency of the process.
- Early building blocks, which convert to advanced intermediates and final APIs via various organic synthesis routes.
- Application of cost-effective methodologies.
Intellectual Property Management (IPM)
ROLES
- Innovation support
- Infringement Screening
- IP-Validation
- FTO-Analysis
- Patent drafting
- Patent Filing
- IP-Alerts
TOOLS/DATABASES
- CAS Scifinder
- United States Patent & Trademark Office
- European Patent Office
- WIPO
- Scopus
- PubMed
TALENT POOL
- Registered Indian Patent Agent With Organic Chemistry Postgraduates & Ph.Ds.
- Experts in data mining in literature databases and interpretation of techno legal documents
- 15+ Years of Experienced Resources
QUALITY & INFORMATION SECURITY
- ISO 9001 - Quality Assurance
- Non-Disclosure Agreements (NDA)
- Data Security Softwares
INITIATIVE – GREEN CHEMISTRY
- Synthetic methods are designed to maximize the incorporation of all materials used in the process into the final product.
- Minimizing the consumption of organic solvents and employing in water, enabling the processes ”Greener”
Following applications of Green Chemistry are witnessed at VNAI:
- Prevention of Toxic chemicals
- Ensuring Atom economy
- Less hazardous chemical syntheses
- Designing safer chemicals
- Safer solvents and auxiliaries
- Design for energy efficiency
- Use of renewable feed stocks
- Reduce derivatives
- Catalysis
- Telescopic Approach
| S.No. | Green principles | Key Focus Areas | Case Study |
|---|---|---|---|
| 1 | Prevention of Toxic chemicals | Toxic chemical has been replaced. | Exploration of Biocatalysis process instead of chemical. |
| 2 | Ensuring atom economy | Good atom economy - Most of the atoms of the reactants are incorporated in the desired products. | Lacosamide & Olmesartan |
| 3 | Less hazardous chemical syntheses | Designed synthesis – Replacement of Toxic to Non-toxic chemicals. | Pyrophoric chemicals are replaced with simple RMs with modified approach – Loxoprofen |
| 4 | Designing safer chemicals | Ease of operation | Multiple approaches |
| 5 | Safer solvents and auxiliaries | EHS Convenient | Promoted water based reactions |
| 6 | Energy efficiency, Reduce Waste & Catalysis | Combined effect – Lowering activation Energy | Olmesartan Medoxomil, Loxoprofen Na Hydrate. |
| 7 | Telescopic Approach | One-pot synthesis | Lacosamide, Olmesartan, Vildagliptin, Loxoprofen & CMO |