Khandelwal Labs

KHANDELWAL LABS

OVERVIEW KLab manufactures, markets and out-licenses patented Pharmaceutical Formulations, NDDS, niche API’s and chiral intermediates. KLab’s major sales are from patented products from in-house R&D. Cefi-XL our patented antibiotic combination is the No.1 launched new product in India in last 2 years as per July 2006 IMS report. KLab has more than 150 patents granted/pending using NDDS, Nanotechnology, Dendrimers and Chiral Chemistry. KLab has over 2000 employees. The sales force comprises around 1500 persons who cover 250,000 Doctors, 100,000 Pharmacies and 1500 Stockists in India every month. KLab has a unique intelligent monthly incentive system which enables more than 60% of its sales persons to earn more than 50% of their salaries by way of incentives. KLab has launched six speciality divisions operating in different therapeutic areas, to enable focus on maximum new product launches. KLab is a key player in India in the niche areas of oncology, antibiotics, pain and spasm Management. KLab is a pioneer to bring oncology products in India and has a dedicated formulation and API facility focused on the developing countries. KLab also provides contract manufacturing for more than 10 companies.

KLab is ranked 57th in the Indian Pharmaceutical Industry As per IMS ORG, & KLab is ranked 26th as per its covered market and is growing above 30% per annum. Within next 3 years, KLab plans to be around number 10th rank in its covered market. HISTORY Products & Services Establishment Year

» Manufacturer of Formulation,Bulk drugs. » 1945

FROM INLICENSING INTO INDIA TO OUTLICENSING TO THE WORLD. Past Created Markets in India Oncology - Cyclophosphamide, Cisplatin, Bleomycin Nippon Kayaku (Japan) / Asta Medica (Germany). Pain and Spasm – Camylofin and Methocarbamol Asta Medica / A.H. Robins (USA). Anaesthetic – Glycopyrrolate – A.H. Robins Respiratory Stimulants – Doxapram – A.H. Robins. Iron Supplements – Iron Polymaltose – Hausmann Laboratories (Switzerland). Anti-tussive – Prenoxdiazine – Chinoin (Hungary) Present Introduced Patented Products based on NDDS (Marketed in India and out-Licensed for the Developing Countries) Camylofin combinations with Nimesulide/ Diclofenac – ANAFORTAN GROUP Methocarbamol combinations with Diclofenac / Nimesulide.- ROBI GROUP Cefixime once a day - CEFI OD. Cefixime + Cloxacillin + Lactobacillus - CEFI XL. Future

VISION MISSION HEAD OFFICE CORPORATE OFFICE KHANDELWAL LABORATORIES PVT. LTD 79/87 D.LADPATH MUMBAI 400 033, INDIA PH : (91)(22)23718238/46 Fax : (91)(22)23739381 Email : [email protected] [email protected] Human Resource Email : [email protected] Marketing International PH : (91) (22) 23724214 Email : [email protected] Marketing Domestic Email : [email protected]

FINANCIAL HIGHLIGHTS

Firm Type » Private Ltd. Annual Turnover » 10-100crores Branches » Rajeha Center & Chinchpokli (H.O.)

R&D  K - NDDS ( Novel Drug Delivery System)

NDDS Research is focused in the areas of colon delivery, Brain delivery, osmotically engineered systems controlled delivery, biologically degradable polymers in controlled drug delivery and site specific drug delivery for enhanced efficacy and reduced toxicity. At present our novel drug delivery systems are being developed mainly in the therapeutic areas like Antibiotics Cardiovascular, Respiratory, Oncology and NSAID’S . aColon Targeted Drug Delivery Anti Cancer Drugs : 5-Flurouracil, Oxaliplatin Leucovorin Anti Inflammatory and Anti Spasmodic Drugs : Mesalazine, Corticosteroids, Camylofin . Anti-Protozoal Drugs : Metronidazole, Tinidazole, Secnidazole Brain Targeted Drug Delivery Neurological Drugs : CNS Drugs, Dopamine Site Specific Drug Delivery Anti-cancer Buccal Patches :

Bleomycin

Topical Formulations : Methotrexate Muco Adhesives Osmotically Engineered Systems

Gastric Retention Systems Gastroprokinetic Drugs: Ondansetron Oral Delivery of Parentrals Vaccines, Peptides and other Parentrals Drugs Modified Release Systems Gastric Retention Systems : Gliclazide SR Tablets, Metformin and Gliclazide SR Tablets, Metoprolol SR Tablets Multiple release Systems : Cefixime OD Tablets, Cefixime +Cloxaciline+ Lactobacillus Tablets Matrix & Hydrogel Diffusion Systems : Ofloxacin OD Tablets, Metformin SR Tablets, Cefpodoxime Proxetil OD Tablets,  K - Chirals ( Multi Functional Chiral Pools )

Chiral Synthesis has become important in research and Industry due to the need for increased pathways for identifying active enantiomers in the rascemic mixture. This leads to strong and fast growing range of new chiral building blocks, chiral catalysts and the increased use of chiral biotransformation in organic synthesis. CHIRAL COMPOUNDS Carbohydrate range Monosaccharide derivatives. 1, 2-Amino Alcohol 1, 2 –Amino Alcohol Oxazolidinones

Tartaric acid Derivatives Oxazolidinones Resolving agents  K-DENDRIMERS

Dendrimers are an exciting new class of Macromoleculecular architecture and an important component in the area of nanoscience and technology KLab offers cost effective solutions for surface modified polyamino Dendrimers and their application to cosmetics & antimicrobial formulations. Our in-house R&D is engaged in combining the architecture modification of Dendrimer systems using the concept of supramolecular chemistry to provide custom made Dendrimers. These Dendrimers can be conveniently used in cosmetic preparations to treat varieties of skin conditions. They are also useful in delivery of metal ions in to the skin. They can be used for targeting drugs to different organs. They have a vast application in Biotechnology.  NANOTECHNOLOGY

Patented metal nano particles like gold, iron, silver, copper in biological cells systems. Silver nano gel is soon going to be launched for use in burns, wounds, and acne. Tagging of Antibiotics with Metal Nanoparticles Potential Areas: Antiviral agents Anticancer Agents

Anti Malarial Agents Diagnostics

Present Research Products: Cosmetics Anti Microbials

CLINICAL RESEARCH KHANDELWAL CLINICAL RESEARCH SERVICES (KCRS ONCO) KCRS has access to 5 decades of relationships with the major oncologists and also major oncology institutions in India. KCRS provides overseas companies, including CROs (Contract Research Organization), SMOs (Site Management Organization) and Pharmaceutical Companies with local infrastructure and expertise to ensure that the trials conducted in India are of the highest quality complying with ICH GCP Guidelines and done as speedily as possible. KCRS has access to clinical co-ordinators experienced in the field of oncology as also CRC's who can be placed at the sites to ensure that the trials being done are of the highest standards and with the best personalized handling of the patients which ensures minimal dropouts. Since KCRS has no conflict with any of the CROs and SMOs we have access to all of them and can draw upon their services depending upon requirement. This enables us to draw on expertise available with the various individuals/CROs/SMOs, etc. available in India. We also have close association with the GCP training Institutes and GCP trainers.

Our strength is our specific understanding of oncology, the oncology institutions, oncologists and the regulatory authorities.

PROOF OF CONCEPT STUDIES We have tie-ups with Rural State of the Art Hospitals. These hospitals have a huge population of volunteers and patients with excellent investigation. We have excellent relations with all the necessary institutes and authorities. We can arrange Proof of Concept Studies to establish the basic relations between cause and effect by appropriate trials done most scientifically and speedily

PRODUCTION FACILITIES MANUFACTURING. (WHO – GMP Approved)

GENERAL FORMULATIONS FACILITY. ( For Tablets, Capsules and Liquid Injection ) New facility as per latest international guidelines Separate AHU system for different areas where product is exposed. Dust free granulation system. All the material movement from sifter till compression will be by bins. Auto lifting and tilting devices for loading and transfering the product. Reverse osmosis system and electronic system for generating

purified water Tablets Form

Volume

Capacity / day

Capacity / month

Tablets

Uncoated

2,500,000

30,000,000

General

Coated

2,000,000

24,000,000

Liquid injectable facility Form

Volume

Capacity / day

Capacity / month

Ampoules

Up to 5ml

150,000

39,000,000

Ampoules

10 ml

50,000

1,300,000

Vials

Up to 20 ml

50,000

1,300,000

Dedicated cephalosporin tablets facility Form

Volume

Capacity / day

Capacity / month

Tablets

Uncoated

400,000

4,800,000

Tablets

Coated

400,000

4,800,000

COMPANIES AND SUBSIDIRIES GLOBAL OPERATION

THERAPEUTIC SEGMENT Therapeutic Categories

Anaesthetics Anti-Hypertensive Anti-Bacterials NSAID’s Anti-Osteoporotics

Anti-Spasmodics Anti-Diabetic Skeletal Muscle relaxants Anti Fungal Anti-Tussives Anti-Ulcerants

MAJOR BRANDS Oncology Formulations BICALUTAMIDE TAB BLEOMYCIN INJ

HYDROXYUREA CAPS IFOSFAMIDE FOR INJ

CARBOPLATIN INJ

IMATINIB MESYLATE CAPS

CISPLATIN INJ

IRINOTECAN HCL INJ

CYCLOPHOSPHAMIDE FOR INJ

LIPOSOMAL AMPHOTERICIN HCL INJ

DOXORUBICIN INJ

METHOTREXATE TAB

EPIRUBICIN HCL INJ

PACLITAXEL INJ

ETOPOSIDE CAPS

TAMOXIFEN CITRATE TAB

FLUROURACIL INJ

VINCRISTINE SULPHATE INJ

GEMCITABINE HCL FOR INJ

Patented Products KLab is already marketing some of its patented products through its various divisions. ANAFORTAN Group– Combinations with Antispasmodic Camylofin DiHCl ROBI Group – Combinations with Methocarbamol Muscle Relaxants CEFI Group – Combinations of Cefixime

Antibiotic

PRENOXID – Prenoxdiazine HCl

Antitussive

Oncology API KLab has a dedicated oncology facility for manufacturing various APIs. KLab also has a separate sterile powder manufacturing facility. Carboplatin Cisplatin Cyclophosphamide 5-Fluorouracil Gemcitabine Hydroxyurea Methotrexate Tamoxifen

Specialty APIs KLab is manufacturing these specialty APIs majorly for its own captive consumption. Camylofin DiHCl Doxapram Hydrochloride Glycopyrrolate Methocarbamol Prenoxdiazine Hydrochloride

RECENT DEVELOPMENT

New Facility In Uttaranchal As Per Latest USFDA guidelines. Manufacturing Unit for General Tablets and Cephalosporin tablets with full Excise Duty and Sales Tax benefits.

CARERR OPURTUNITIES KLab manufactures, markets and out-licenses patented Pharmaceutical Formulations, NDDS, niche API’s and chiral intermediates KLab’s major sales are from patented products from in-house R&D. Cefi-XL our patented antibiotic combination is the No.1 launched new product in India in last 2 years as per July 2006 IMS report. KLab has more than 150 patents granted/pending using NDDS, Nanotechnology, Dendrimers and Chiral Chemistry.

KLab has over 2000 employees. The sales force comprises around 1500 persons who cover 250,000 Doctors, 100,000 Pharmacies and 1500 Stockists in India every month. KLab has a unique intelligent monthly incentive system which enables more than 60% of its sales persons to earn more than 50% of their salaries by way of incentives. KLab has launched six speciality divisions operating in different therapeutic areas, to enable focus on maximum new product launches.

The Board Mr. R.V.S.Mani ( Whole time Director ) Mr. Sanjeev Khandelwal (Chairman & Managing Director) Mr. Vijay Goel

CONTACT INFORMATION Address » 79/87, D.Lad Path, P.o.Box no 7808. Mumbai - 400033 ( Maharashtra ) - India Contact Person » Mr. Arun Gothe Phone (Off.) » 022-23718238, 566, 23719736/43 Web-Site » http://www.kgenix.com E-mail » [email protected]

Philosophy. The Individual The individual is at the heart of our creative process. We identify innovative individuals and partner with them. The scientist works best in institutions, which facilitate open-ended thinking. We access the scientists in their own habitat without dislocating them. Majority of the brilliant scientists and intellectual property is still untapped, as conventional thinkers cannot understand the opportunity. The companies of the future are still unknown and available.

All the creators of knowledge and wealth shall enjoy the fruits of their creation fairly. The internet has made the individual extremely powerful. We develop our own unique strategies and implement them. Intellectual Property Intellectual Property We create our own intellectual property using brilliant individuals and the latest technologies. We have cross-hierarchical multifunctional networks of experts from within the company and outside institutions to feed our creative process. Technology We use the latest technology to access available knowledge intelligently using multidisciplinary world class minds to create simple products with unique benefits. Nature is largely unknown Nature is simple. The future solutions have to be simple and efficient based on these principles. Since only1.5% of Nature is known (1.5% of the DNA is mapped, 98.5% was termed as Junk DNA which has now got some function) and a large part of nature is still unknown. OUR RULE – NO RULES We have a unique system whereby we question and review all the rules and keep redefining them as we go along