An ISO 9001-2000 and WHO GMP certified company manufacturing bulk drugs and intermediates like ranolazine, 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 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

• Custom Chemical Synthesis


• DMF Status


• Systeam and Audites from the Brouches

Our Products:

• Products under Saleup




• Ranolazine


• Terbinafine Hydrochloride


• Topiramate


• Voriconazole




• Products under Development




• Ibuprofen Piconol


• Nebivolol


• Olmisarten


• Pramipexole Dihydrochloride Monohydrate


• Prasugrel


• Repaglinide


• Ropinirole


• Sitagliptin


• Tolterodine Tartrate


• Vildagliptin.
  

Bulk Actives

1. 
   

   Carvedilol
   (CAS No. 72956–09-3)

   
   


2. 
   

   Carvedilol
   Phosphate (CAS No. 610309-89-2)

   
   


3. 
   

   Citalopram
   Hydrobromide (CAS No. 59729-32-7)

   
   


4. 
   

   Duloxetine
   Hydrochloride (CAS No. 136434-34-9)

   
   


5. 
   

   Escitalopram
   oxalate (CAS No. 219861-08-2)

   
   


6. 
   

   Ondansetron
   hydrochloride dihydrate (CAS
   No.99614-01-4)

   
   


7. 
   

   Oxatomide
   (CAS No. 60607-34-3)

   
   


8. 
   

   Sertraline
   hydrochloride (CAS No. 79559-97-0)

   
   


9. 
   

   Rivastigmine
   hydrogen tartrate (CAS
   No.129101-54-8)

   
   

Newly
Introduced API’s

10. 
    

    Ranolazine
    (CAS No 142387-99-3)

    
    


11. 
    

    Rosiglatazone
    Maleate ( CAS No 155141-29-0)

    
    


12. 
    

    Carbidopa
    (CAS No 38821-49-7)

    
    

Carvedilol Intermediates

• 
  

  1,3-Cyclo
  hexane dione (CAS No.504-02-9)

  
  


• 
  

  1,2,3,9-Tetrahydro-4H-carbazol-4-one
  (CAS No.15128-52-6)

  
  


• 
  

  4-Hydroxy
  carbazole (CAS No. 52602-39-8)

  
  


• 
  

  4-(2,3-Epoxy
  propoxy) carbazole (CAS No. 51997-51-4)

  
  


• 
  

  2-(2-Methoxy
  phenoxy)ethylamine (CAS No.1836-62-0)/HCL (CAS No.64464-04-9)

  
  


• 
  

  N-[2-(2-Methoxy
  phenoxy) ethyl] benzyl amine (CAS No.3246-03-5)/ HCL

  
  

Citalopram
/ Escitalopram intermediates

• 
  

  4-[(4’-Dimethyl
  amino)-1-(4”-fluorophenyl)-1-hydroxy butyl]-3-(hydroxy methyl)
  benzonitrile hydrobromide (CAS No. 103146-26-5)

  
  


• 
  

  4-[(4’-Dimethyl
  amino)-1-(4”-fluorophenyl)-1-hydroxy butyl]-3-(hydroxy methyl)
  benzonitrile (CAS No. 103146-25-4)

  
  


• 
  

  4-[(4’-Dimethyl
  amino)-1-(4”-fluorophenyl)-1-hydroxy butyl]-3-(hydroxy methyl)
  benzonitrile hydrochloride (CAS No. 717133-25-0)

  
  


• 
  

  Citalopram
  base (CAS No. 59729-33-8)

  
  


• 
  

  1-(4’-Fluoro
  phenyl)-1,3-dihydro iso benzofuran-5-carbonitrile (CAS No.
  64169-67-1)

  
  


• 
  

  5-Bromo-1-(3-dimethyl
  amino propyl) –1-(4’fluoro phenyl)-1,3-dihydro isobenzofuran
  oxalate

  
  


• 
  

  1-[3-(Dimethylamino)-propyl]-1-(4fluoro
  phenyl)-5-phthalan carbonitrile HCl

  
  


• 
  

  (+)-Dipara
  tolouyl–d-tartaric acid salt of 4-[(4’-Dimethyl
  amino)-1-(4”-fluorophenyl)-1-hydroxy butyl]-3-(hydroxy methyl)
  benzonitrile (CAS
  No. 128173-53-5)

  
  


• 
  

  3-DImethyl amino
  propyl chloride hydrochloride 

  
  


• 
  

  Citalopram
  HCl (CAS No. 85118-27-0)

  
  

Ondansetron
hydrochloride dihydrate

• 
  

  9-Methyl-1,2,3,9-tetra
  hydro 4H carbazol-4-one (Cas No. 27387-31-1)

  
  


• 
  

  3-[(NN-Dimethyl
  amino) methyl]-9-methyl-1,2,3,9-tetra hydro 4H-carbazol-4-one
  hydrochloride (CAS No. 119812-29-2).

  
  


• 
  

  Ondansetron
  base (99614-02-5).

  
  

Duloxetine
intermediates

• 
  

  3-Dimethyl
  amino-1-(2-thienyl)-1-propanone hydrochloride (CAS No.5424-47-5)

  
  


• 
  

  RS-N,N-Dimethyl-3-hydroxy-3-(2-thienyl)-1-propanamine(CAS
  No.116817-84-6)

  
  


• 
  

  S(-)-N,N-Dimethyl-3-hydroxy-3-(2-thienyl)-1-propanamine
  (CAS No.132335-44-5)

  
  


• 
  

  RS-N,N-
  Dimethyl-3-(1-Naphthalenyloxy)-3-(2-thienyl)-1-propanamine oxalate

  
  


• 
  

  S-(+)-N,N-Dimethyl-3-(1-Naphthalenyloxy)-3-(2-thienyl)-1-propanamine
  oxalate (CAS No.132335-47-8)

  
  

Ranolazine
intermediates

• 
  

  2-chloro-N-(2,6-dimethylphenyl)acetamide
  - CAS No (1131-01-7)

  
  


• 
  

  N-(2,6-dimethylphenyl)-2-(piperazin-1-yl)acetamide
  – CAS No. (5294-61-1)

  
  


• 
  

  2-((2-methoxyphenoxy)methyl)oxirane
  - CAS No. (2210-74-4)

  
  

Rivastigmine
intermediates

• 
  

  -(meta
  hydroxy phenyl) ethyl dimethyl amine (CAS No 105601-04-5) / HCl (CAS
  No. 5441-61-2)

  
  


• 
  

  S
  (+)-(
  meta hydroxy phenyl)ethyl dimethyl amine (CAS No. 139306-10-8)

  
  


• 
  

  Racemic
  Rivastigmine hydrochloride (CAS No. 105601-14-7)

  
  

Repaglinide

• 
  

  N-Acetyl
  glutamic acid salt of S-(2-pyridino-phenyl)-3-methyl-1-butylamine

  
  

Valsartan

• 
  

  L-Valine
  methyl ester hydrochloride (CAS No.6306-52-1)

  
  


• 
  

  L-Valine
  benzyl ester hydrochloride (CAS No.2462–34-2)

  
  


• 
  

  N-[(2'-Cyanobiphenyl-4-methyl)-(L)-Valine 
  methyl ester Hydrochloride

  
  

- CAS No (137863-89-9)

Voriconazole
intermediates

• 
  

  2-Chloro-6-ethyl-5-fluoro-4-hydroxy
  pyrimidine ammonium salt

  
  


• 
  

  4-Chloro-6-ethyl-5-fluoro
  pyrimidine (CAS No. 137234-74-3)

  
  


• 
  

  4-(1-bromo
  ethyl)-6-chloro-5-fluoro pyrimidine (CAS No. 188416-28-6)

  
  

Darifenacin
intermediates

• 
  

  3-(S)-(+)-(1-carbamoyl-1,1-diphenylmethyl)
  pyrrolidine - L-(+)-tartrate

  
  
  
  
  • 
    

    CAS No
    (134002-26-9)

    
    
  
  
  
  


• 
  

  5-(2-chloroethyl)-2,3-dihydrobenzofuran
  – CAS No (943034-50-2)

  
  

Vildagliptin
intermediates

• 
  

  (S)-1-(2-chloroacetyl)pyrrolidine-2-carbonitrile
  -CAS No (207557-35-5)

  
  

Sitagliptin
intermediates

• 
  

  3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine
  hydrochloride– CAS No (762240-92-6)

  
  

Other products

• 
  

  N-Methyl-1-Naphthyl
  methyl amine hydrochloride (CAS No. 65473-13-4) (for Terbinafine and
  Butenafine)

  
  


• 
  

  2,3:4,5-Bis-O(1-methylethylidene)--D-fructopyranose(CAS
  No.20880-92-6) (Topiramate intermediate)

  
  


• 
  

  N-Boc-Prolinamide
  (CAS No. 15761-39-4)

  
  


• 
  

  L-Prolinamide
  (CAS No. 7531-52-4)

  
  


• 
  

  2-Methyl
  cyclohexane 1,3-dione (CAS No 1193-55-1)

  
  


• 
  

  6-Chloro
  oxindole (Ziprasidone Intermediate) – CAS 56341-37-8

  
  


• 
  

  (+)-O,O-
  Di-p-toluoyl-D-Tartaric acid -((+)-DPTTA) - CAS No 32634-68-7

  
  


• 
  

  (-)-O,O-Di-p-toluoyl-L-Tartaric
  acid – ((-)-DPTTA)- CAS No 32634-66-5

  
  

Products
under development

• 
  

  Voriconazole

  
  


• 
  

  Nebivolol

  
  


• 
  

  Valsartan

  
  


• 
  

  Pramipexole

  
  


• 
  

  Pregabalin

  
  


• 
  

  Repaglinide

  
  

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.