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MANUFACTURING
We have invested in the best of infrastructure, for, we at Shodhana 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
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 for Duloxetine Hydrochloride and TDMFs ( Taiwan) for Carvedilol, Duloxetine Hydrochloride, Escitalopram Oxalate, Ondansetron Hydrochloride Dihydrate and Citalopram Hydrobromide.
OUR CEP/COS STATUS
OUR CEP/COS STATUS
(CEP 2008 - 259)
Carvedilol - COS/ CEP granted
(CEP 2008 - 259)
Carvedilol - COS/ CEP granted
(Rl-CEP 2010-228-Rev 00)
Citalopram Hydrobromide - COS/CEP granted
(RPCEP 2013-340-Rev 00)
Duloxetine Hydrochloride - COS/CEP granted
(RO-CEP 201S-236-Rev 00)
Rivastigmine - COS/CEP granted
