Profile
A WHO GMP and ISO 9001-2000 certified company, Shodhana
Laboratories is considered to be one of the most dynamic pharma
intermediates, pharma chemicals manufacturing companies. We offer a wide
range of active ingredients, intermediates and other products for
pharmaceutical application.
Today, we have the technically most advanced production facilities and our
entire manufacturing process is as per ICH & cGMP guidelines. We also
have a world class R&D lab manned by a dynamic team of highly qualified
and experienced scientists.
Our motto is to achieve Total Customer Satisfaction. Our endeavor is to
continuously offer effective and reliable products at most competitive
prices within scheduled time frame. Support the Manufacturers (Pre Sale &
Post Sale) with necessary documentation.
Our Mentors & Team
The company is established and headed by a technocrat who
has more than 20 years of rich experience in pharmaceutical industry. He has
worked with blue chip companies like Warner Hindustan, Standard Organics
etc. Besides these companies, he had also held the position of Senior VP -
Technical and Bulk operations in Cheminor Drugs, a Dr Reddy's group company.
In his present endeavor he has been accompanied by a doctorate who has 17 to
20 years experience in R& D and also other professional who have 20-25
years of experience in production.
Our Products Range
We offer various types of pharma intermediates and
pharma chemicals for pharmaceutical drugs. These products are manufactured
strictly as per GMP Q7A Guidelines.
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- 1,3- Cyclohexanedione
- L-Valine methyl ester hydrochloride (Valsatran
Intermediate)
- N-Methyl-1-Naphthyl methylamine hydrochloride
(Terbinafine Intermediate)
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- Carteolol hydrocloride
- Clonixin lysine
- Ibuprofen piconol
- Nebivolol
- Pramipexole dihydrochloride monohydrate
- Raloxifene hydrochloride
- Repaglinide
- R-Ondansetron
- Rosiglitazone maleate
- Tolterodine tartrate
- Topiramate
- Voriconazole
- Prosugrel
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Our Services
With state-of-the-art manufacturing facilities, we even
undertake custom synthesis and contract manufacturing. We are already
dealing with number of MNC companies. Having a team of core technical
experts to handle tough chemistry, we welcome our customers for custom
synthesis and contract manufacturing.
Our Strength
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Capabilities to carry
out various chemical reactions to name few : |
- Good knowledge of cGMP requirements, regulatory requirements,
systems development and implementation
- Competent in DMF preparations and filing
- Awareness to US FDA and other regulatory inspections.
- Good Knowledge of polymorphism, which includes preparation of
different polymorphs in manufacturing scale, analysis by powder XRD,
DSC & IR as well as their interpretation
- Good Knowledge in Patent evaluation, implications and patenting
processes
- Several Patents in the name of CEO and VP - Technical
- Being filed 5-10 process patents
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- Resolutions & racemizations
- Reductions
- Oxidations (KMnO4,Oppenaeur, periodate)
- Dieckmann Reaction · Darzen's glycidic ester synthesis
- Alkylations
- Grignard reactions
- Experienced in handling chemicals like phosphorous oxychloride,
thionyl chloride, Bromine etc.
- Cyclisations
- Amidations
- Fischer indole synthesis
- Aromatisations
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Vision
"To achieve and establish a reputation for our
technical capabilities, cGMP commitments and deliveries."
Mission
Our mission is to achieve a turnover of Rs 1500 million
by 2010 and we have been working hard by -
- Introducing One bulk active to the existing product range every year
- Take the existing molecules to regulated markets
- Establish tie-ups with reputed organizations for their bulk product
requirements
- Custom synthesis / Contract Manufacturing
Achievements & Accreditions
Since our establishment, we have achieved several
milestones as the manufacturer of active pharma intermediates, pharma
chemicals and intgredient for pharmaceutical applications. Some of our
achievements are:
- WHO GMP certification and ISO 9001-2000 certification
- Decent turn over from exports
- Availability of DMF for all products
- Filed and accessed DMF for Carvedilol, present in Europe market
- Filed and accessed Citalopram DMF in UK and supplying the product
Infrastructure

Located
in Hyderabad (30 to 45 Minutes from Air Port), we have a state-of-the-art
infrastructural set-up with the most advanced equipments and machineries.
Being at Hyderabad, we have an edge in terms of material sourcing,
exporting, business networking, etc. Further, at our unit, there are
integrated sections for production having 35 reaction vessels, quality
testing, product packaging and storage facilities. This assists us for
organized and timely execution of entire business orders. Some of the
salient attributes of our infrastructure are:
- Established R&D along with necessary supporting equipment and a
team of 25 Scientists.
- Spacious warehouse as per cGMP norms
- Multiple effect operations to handle effluent
- Two Supporting Manufacturing facilities in and around Hyderabad with
total 30 reaction vessels
- Integrated well-equipped quality control lab
- Established Class 100,000 cleanroom consisting of 2 reaction vessels
for wet product
- Separate drying and packing areas for products
Facilities

In
addition to our modern infrastructure set-up, we also have the following
facilities:
- 2 acre land in Jeedimetla, Hyderabad for future production expansion
- 4.5 acre land in Vizag Pharma city for future expansion
Quality
We are committed towards furnishing superior quality
products. For that a team of pharmaceutical quality control experts minutely
scan each and every stage of production. We have integrated quality control
lab which is well-equipped with requisite equipment such as GC (Head space
and normal), HPLC systems, UV, FTIR spectrophotometers and Autopol
polarimeter. These machines are used to carry out impurity profiles and
regular analysis of products.
Clientèle
We work with a highly professional approach, which is
orientated to achieve desired results while maintaining entire ethical
business practices. With this we are working with several clients world
wide.
DMF Status
| Product |
Submitting Authority |
DMF Number |
| Ondansetron hydrochloride Dihydrate |
Infarmed, Portugal |
179/2007 |
| Escitalopram Oxalate |
Infarmed, Portugal |
194/2007 |
| Carvedilol |
Infarmed, Portugal |
159/2003 |
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State Medicine, Latvia |
Awaited |
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Bulgaria Drug Agency, Bulgaria |
Awaited |
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Ministry of Health Pharmaceutical Sciences |
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Cyprus |
2007-DMF-544 |
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Majadohonda |
CW/1137/03 |
| Citalopram Hydrobromide |
MHRA |
MFD-23099-2-07617-0001 |
:: Our Products ::