Profile

A WHO GMP and ISO 9001-2000 certified company, Shodhana Laboratories is considered to be one of the most dynamic pharma intermediates, pharmaceutical chemicals, 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.

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.

We offer various types of pharma intermediates and pharma chemicals for pharmaceutical drugs. These products are manufactured strictly as per GMP Q7A Guidelines.

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.

• Good knowledge on 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 Post Graduates in Chemistry) guided by a Doctorate in Chemistry with rich experience of 18 years in Dr. Reddy's
• Knowledge on Polymorphism (Preparation of different polymorphs in the lab as well as in manufacturing scale, analysis by powder XRD, DSC & IR and their interpretation)
• The VP Technical and the CEO have several patents to their credit
• Shodhana has eleven Indian Patent applications filed to its credit
• Shodhana has filed one US patent application
• Shodhana has filed six PCT applications (Including one novel polymorph)
• Good Scientific knowledge about process development, scale up and commercialization and adaptation of new processes and technologies
• Shodhana enjoys a status of preferred approved source with many multinational companies (Domestic and International) for their Intermediate supplies

• Resolutions & racemizations
• Reductions
• Oxidations (KmnO4, Oppenaeur, periodate)
• Alkylations
• Mannich Reaction
• Grinard reactions
• Cyclisation
• Amidations
• Fischer indole synthesis
• Aromatization
• Aromatization
• Friedel-Crafts Alkylation

"To achieve and establish a reputation for our technical capabilities, cGMP commitments and deliveries."

The company has strong R&D that works round the clock under the able guidance of a well experienced Doctorate in chemistry. It has proven track record for their Custom Chemical Synthesis. The company has already developed products for US and Australian markets and provided them with gram level quantities to hundred kilogram quantities. Besides successfully fine tunning several rough processes in lab, Shodhana has also capabilities to develop new/novel/alternate process. Shodhana strong in scaling up lab process to kilogram scale and even 100's kilogram scale.

To introduce minimum 2 bulk actives besides intermediates, every year to support global pharmaceutical industry in API/KSM supplies, custom synthesis and contract manufacturing.

Shodhana Laboratories was established in September 2000 by a technocrat entrepreneur with a Doctorate in Chemistry, after gaining 20 years of rich industrial experience in various organizations that include Standard Organics, Cheminor Drugs, (Dr. Reddy's) from its inception in 1984 till 2000 as Sr. Vice President (Technical and Bulk Operations). The Company is supported by a well experienced technical staff in Research and Development and Manufacturing.

Since our establishment, we have achieved several milestones as the manufacturer of active pharma intermediates, pharma chemicals and ingredient for pharmaceutical applications. Some of our achievements are:

• WHO GMP certification and ISO 9001-2008 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

• Carvedilol - COS/ CEP granted (CEP 2008 - 259)
• Ondansetron Hydrochloride Dihydrate - COS / CEP under review (CEP 2009-114)
• Citalopram Hydrobromide - COS/CEP under review (CEP 2010-228)

The company has filed EDMFs for Carvedilol, Escitalopram Oxalate, Ondansetron Hydrochloride Dihydrate, Rivastigmine Hydrogen Tartrate, Citalopram Hydrobromide and UK DMF for Citalopram Hydrobromide. The company has been supplying its bulk actives to these markets and to other countries like Mexico, Iran, Brazil, Chile, Japan, Singapore, Malaysia, South Africa, Spain, Portugal, Latvia, Argentina besides the local domestic market.

• 2000sq. Meters established R & D with all the necessary equipment.
• Roto evaporators, Autoclaves, Fume hoods etc.
• An additional R & D facility of 400sq. Meters is under commissioning.

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
• Four 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

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

Shodhana has Stainless Steel and Glass lined reaction vessels of various sizes amounting to about 120KL reaction volume. This equipment includes pressure vessels also. Besides the main facility, Shodhana has also other subsidiary units in and around Hyderabad holding reaction volume of additional 100KL Shodhana regularly carries out catalytic hydrogenation under pressure. Our facilities have multiple effect evaporators for handling effluents and solvents efficiently. Shodhana has three clean rooms (Class 100,000) for handling last stage of API.

The group has several tray driers, FBDs, Rota cone vacuum driers, Vacuum tray driers, Spin flash drier for their needs. All the facilities are equipped with standby power generators to cater the needs in case of main power failures. All the facilities are equipped with sufficient boiler, chilling plants, hot oil circulation systems (for high temperature reactions and distillations), scrubbers and other utilities to cater the exi$tinq needs.

The company has acquired another company adjacent to Shodhana with an area of about 8000sq. Yards with constructed buildings for its expansion. Shodhana has taken about 5 acres of land in Jawaharlal Nehru Pharma City near a sea port city Vizag Andhra Pradesh, (India) a site that has been developed by the Government of A.P. For Chemical industries with all the necessary effluent treatment facilities..

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.

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.