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 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
• Rosiglitazone Maleate
• 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)

Rosiglitazone intermediates

• 4-(2-(N-methyl-N-(2-pyridyl)amino)ethoxy)benzaldehyde – CAS No (122321-03-3)

• 2,4-Thiazolidinedione – CAS No. (2295-31-0)

• 5-[4-[2-[N-Methyl-N-(2-pyridinyl)amino]ethoxy]benzylidene]-2,4-thiazolidinedione- CAS No.(122320-74-5).

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)

• 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

• Tramadol HCl

• 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.