An ISO 9001-2000 and WHO GMP certified company manufacturing bulk drugs and intermediates like ranolazine, rosiglitazone maleate, terbinafine hydrochloride, topiramate, voriconazole...
Making Our Mark
Shodhana Laboratories was established in September 2000 by a technocrat entrepreneur with a Doctorate in Chemistry and after gaining 20 years of rich industrial experience in various organizations that includes Standard Organics, Cheminor Drugs (Dr.Reddy's), from its inception in 1984 till 2000 as Senior Vice President (Technical and Bulk Operations).
The company is supported by a well-experienced technical staff in Research & Development and with 7 to 18 years of R&D and Manufacturing.
Tested Strength & Capabilities
- Good knowledge of cGMP requirements, regulatory requirements, DMF preparations and filing, systems development and implementation
- The team has exposure to US FDA inspections in their earlier organizations
- Patent evaluation, Implications and Patenting processes
- 20 scientists (Graduates and Postgraduates) guided by a Doctorate in Chemistry with rich experience of 18 years in Dr. Reddy's
- Knowledge of polymorphism (preparation of different polymorphs in lab as well as in manufacturing scale, analysis by powder XRD, DSC & IR and their interpretation)
- Shodhana has several patents filed to its credit and it is in the process of filing few more
- Good scientific knowledge about process development, scale up and commercialization and adaptation of new processes and technologies.
Hands on Experience in Chemical Reactions
- Resolutions & racemization
- Reductions
- Oxidations (KMn04, Oppenaeur, Periodate)
- Dieckmann Reaction
- Darzen's glycidic ester synthesis
- Alkylations
- Grignard reactions
- Cyclizations
- Amidations
- Fischer indole synthesis
- Aromatizations
- Hydrogenations.
Hallmarks
- Bulk drugs and intermediates prepared as per cGMP requirements and other regulatory requirements
- Team's exposure to US FDA inspections as part of experience, ensuring high quality production
- Evaluation of patent, implications and patenting process to deliver the best
- A team of 20 scientists engaged in research & Development and processing effective bulk drugs and intermediates
- Several patents filed to its credit with new ones in the pipeline
- Filing for PCT application for a new polymorph in one of its products
- Adaptation to new processes and technologies and upgradation as per the same
- An approved source for supply of bulk drugs and intermediates for a number of domestic and international companies.
Our Products
- Products under Saleup
- Ranolazine
- Rosiglitazone Maleate
- Terbinafine Hydrochloride
- Topiramate
- Voriconazole
- Products under Development
- Ibuprofen Piconol
- Nebivolol
- Olmisarten
- Pramipexole Dihydrochloride Monohydrate
- Prasugrel
- Repaglinide
- Ropinirole
- Sitagliptin
- Tolterodine Tartrate
- Vildagliptin.
Future Endeavor
- Become a renowned company with turnover of over US$ 35 million by 2010
- Introduce at least one bulk active besides intermediates every year
- Take existing molecules to regulated markets
- Establish tie-ups with reputed organizations for mutual business profits
- Setting up of a plant at Jawaharlal Nehru Pharma City, Vizag very soon.
Strength
At Shodhana Laboratories, we comply to and have a good knowledge of cGMP requirements, regulatory requirements, DMF preparations and filing, systems development and implementation. We also have a good knowledge about process development, scale up and commercialization and adaptation of new process and technologies.
Research & Development
The R&D department at Shodhana Laboratories is operational round the clock to successfully develop effective bulk drugs and intermediates as per internationally accepted norms and regulations. The unit is spread at an area of 200 sqm, equipped with all necessary machines like glass equipments, buchi evaporators, autoclaves, fume hoods, etc.
An additional R&D facility spread at 400 sqm is under construction. A team of experts is at the helm of affairs to undertake the entire R&D activities.
Infrastructure
We have a spacious 600Sq. metre ware house to store the raw materials as per cGMP, 25 reaction vessels of various sizes ranging from 100ltrs to 3000ltrs that include stainless steel, Glass lined reactors and autoclaves with supporting equipments. We are also equipped with a spacious quality control lab with necessary GC, HPCL instruments as well as a well equipped R&D wing where our team of researchers work round the clock.
