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Research & Development
At Shodhana we invest significantly in our research talent and capabilities. Research has played a pivotal role in our evolution and it continues to do so even as we explore new grounds. A well equipped in-house R&D centre of excellence manned by a team of scientists drawn from the finest pool of talent enables us to meet all key objectives, in-house; we work on developing processes, develop new products and custom synthesize chemicals, all independently and completely in-house.
At Shodhana Laboratories we invest significantly in our research talent and capabilities. Research has played a pivotal role in our evolution and it continues to do so even as we explore new grounds. Our R&D Centre of Excellence is manned by a team of scientists drawn from the finest pool of talent, enabling us to meet all key objectives, in-house; we work on developing novel processes, develop new products and custom synthesize chemicals, independently.
We have a well equipped R&D Centre with all the necessary infrastructure with instruments, including Roto Evaporators, High-pressure Autoclaves, Fume hoods, etc. A dynamic team comprising of qualified and experienced scientists, work relentlessly on process developments, new product development and Custom Chemical Synthesis. Our domain expertise is also enhanced by several research patents that our team holds, to create the research-driven impact that we enjoy a reputation as per today.
OUR R&D expertise
- Strong track record of products developed for the US, European and Australian markets
- Ability to successfully scale up from the lab, to pilot, to commercial levels
- Ability to successfully optimize processes and develop novel or alternate processes
- Team Shodhana has several patents to its credit
MANUFACTURING
We have invested the best infrastructure, for, we at Shodhana Laboratories believe that the formulation’s efficacy is only as good as the API it is made with. As a vertically integrated company, we depend on our own subsidiary units for early stage intermediates. This way, we not only ensure strict adherence to global quality standards, but also have complete control over the deliveries. Our wide collective experience and know-how in process development, scaling up and commercialization give us an unmatched edge. By adapting new processes and technologies, we offer considerable benefits to our strategic partners who turn to us for their formulation needs.
Our command on pharmaceutical chemistry comes from our exceptional academic grounding in chemistry and years of hands-on experience in
- GRIGNARD REACTIONS
- RESOLUTIONS & RACEMIZATIONS
- REDUCTIONS
- OXIDATIONS
- ALKYLATIONS
- MANNICH REACTION
- CYCLISATION
- AMIDATIONS
- FISCHER INDOLE SYNTHESIS
- AROMATIZATION
- HYDROGENATIONS
- FRIEDEL-CRAFTS ALKYLATION
- DIECKMANN REACTION
Reaching out to over 50 countries, meeting several regulatory requirements and manufacturing for different markets, we are today a repository of expertise on regulatory requirements, cGMP standards, DMF preparations, filing DMFs and systems development and implementation.
We’ve currently filed 80+ DMFs, globally, for a variety of products and have KFDA, TGA, COFEPRIS regulatory approvals.
People from our leadership have several patents to their credit. Shodhana has multiple Indian and US patent applications including a filed PCT application for a novel polymorph.
USDMF FILED | ACCREDITATION OF FOREIGN MANUFACTURER BY PMDA, JAPAN | EU WRITTEN CONFIRMATIONS
Quality Management
As a global supplier in the pharmaceutical domain, we at Shodhana Laboratories, see quality as crucial to our manufacturing and success; we know how the slightest deviation can stop us from meeting our immediate delivery, as well as impact our long term vision. We adopt an overarching quality approach to achieve stringent adherence that percolates down to every level as a series of checks.
As a global supplier in the pharmaceutical domain, we at Shodhana, see quality as crucial to our manufacturing and success; we know how the slightest deviation can stop us from meeting our immediate delivery, as well as impact our long term vision. We adopt an overarching quality approach to achieve stringent adherence that percolates down to every level as a series of checks.
Our integrated quality control lab employs the best from quality control discipline and the finest of analytical equipment including HPLCs, GCs (Headspace and normal), HPLC systems, UV/VIS/FTIR spectrophotometers, Digital polarimeter, and auto titrates for its tests. Consistently carrying out impurity profiling and product analysis is a part of our quality management drill.
Every Centre of Excellence of ours is audited by our domestic as well as international customers. Our ISO 9001-2008 and WHO GMP certification—a status we hold unbroken for years now—is the result of our quality assurance efforts that monitor, guide, audit check, and control every GMP activity.
Regulatory Strengths
Shodhana Laboratories has strong expertise in regulatory frame work and has immense experience in regulatory filings. Shodhana has been supporting top global MNCs for all their regulatory filings and businesses. Shodhana Laboratories has been granted 7 CEPs and filled 80+ DMFs for various products globally. Currently we are supplying our products to more than 50+ countries. Our facility has been audited by stringent global authorities like US FDA, Japan PMDA, KFDA, TGA & COFEPRIS.
Besides playing a crucial role in ensuring complete adherence to the country/region specific regulatory requirements, the team has vast experience in the compilation of DMFs, CTD for submission to regulatory authorities globally including EU/BRAZIL/CANADA/SOUTH AFRICA/MEXICO/TURKEY/JORDAN/IRAN/TAIWAN /INDONESIA, etc. The regulatory team is continuously updated on the global regulatory framework, essential for organizing data generation as per the submission norms mandated in the respective territories.
Shodhana has strong expertise in regulatory frame work and has immense experience in regulatory filings. Shodhana has been supporting top global MNCs for all their regulatory filings and businesses.
Shodhana has been granted 7 CEPs and filled 80+ DMFs for various products globally. Currently we are supplying our products to more than 50+ countries. Our facility has been audited by stringent global authorities like US FDA, Japan PMDA, KFDA, TGA & COFEPRIS.
Besides playing a crucial role in ensuring complete adherence to the country/region specific regulatory requirements, the team has vast experience in the compilation of DMFs, CTD for submission to regulatory authorities globally including EU/BRAZIL/CANADA/SOUTH AFRICA/MEXICO/TURKEY/JORDAN/IRAN/TAIWAN /INDONESIA, etc. The regulatory team is continuously updated on the global regulatory framework, essential for organizing data generation as per the submission norms mandated in the respective territories.
Reaching out to over 50 countries, meeting several regulatory requirements and manufacturing for different markets, we are today a repository of expertise on regulatory requirements, cGMP standards, DMF preparations, filing DMFs and systems development and implementation.
We’ve currently filed 80+ DMFs, globally, for a variety of products and have KFDA, TGA, COFEPRIS regulatory approvals.
People from our leadership have several patents to their credit. Shodhana Laboratories has multiple Indian and US patent applications including a filed PCT application for a novel polymorph.
USDMF FILED | ACCREDITATION OF FOREIGN MANUFACTURER BY PMDA, JAPAN | EU WRITTEN CONFIRMATIONS
OUR DMF STATUS
OUR DMF STATUS
EDMFs
Carvedilol, Escitalopram Oxalate, Ondansetron Hydrochloride Dihydrate, Rivastigmine Hydrogen Tartrate, and Citalopram Hydrobromide.
UK DMF
Citalopram Hydrobromide
US DMF
Duloxetine Hydrochloride
TDMFs (Taiwan)
Carvedilol, Duloxetine Hydrochloride, Escitalopram Oxalate, Ondansetron Hydrochloride Dihydrate and Citalopram Hydrobromide.
OUR CEP/COS STATUS
OUR CEP/COS STATUS
R1-CEP-2008-259-Rev 01
Carvedilol - COS/CEP granted
R1-CEP-2010-228-Rev 01
Citalopram Hydrobromide - COS/CEP granted
R0-CEP-2015-236-Rev 00
Rivastigmine - COS/CEP granted
R1-CEP-2009-114-Rev 00
Ondansetron Hydrochloride Dihydrate - COS/CEP granted
R1-CEP-2013-340-Re 00
Duloxetine Hydrochloride - COS/CEP granted
R0-CEP-2018-278-Rev 00
Escitalopram Oxalate - COS/CEP granted
R0-CEP-2019-066-Rev 01
Rivastigmine Hydrogen Tartrate - COS/CEP granted
