CALCIUM SENNOSIDE SECTION I PRODUCT CHARACTERISTICS AND SPECIFICATION SECTION VII BROAD OUTLINE OF MANUFACTURING PROCESS

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1 CALCIUM SENNOSIDE CONTENTS SECTION I PRODUCT CHARACTERISTICS AND SPECIFICATION SECTION II PRODUCT APPLICATIONS SECTION III INDIAN MANUFACTURERS SECTION IV IMPORT/EXPORT LEVEL SECTION V PRICE TRENDS SECTION VI INDIAN DEMAND SECTION VII BROAD OUTLINE OF MANUFACTURING PROCESS SECTION VIII RAW MATERIAL REQUIREMENTS, UTILITY AND AVAILABILITY SECTION IX GLOBAL SCENARIO SECTION X DISCUSSIONS ON ECONOMIC CAPACITY, PROJECT COST AND PROFITABILITY PROJECTIONS SECTION XI SWOT ANALYSIS SECTION XII FACTORS INFLUENCING THE POSITION FOR A NEW INDUSTRY AND RECOMMENDATIONS 1

2 General details SECITON I PRODUCT CHARACTERISTICS AND SPECIFICATION Appearance : Yellowish brown to Brown powder. Constituent : The major constituent of the sennoside is emodin (1,3,8 trihydroxy-6-methyl-anthroquinone). Solubility : Soluble in water and in dilute alcohol but insoluble in absolute alcohol. Grades : Sennoside content 5% 7% 15% 20% 25% 40% 60% free sennosides 80% Storage : Store in a cool and dry area in sealed containers Process conditions for Sennosides Part of plant used Leaves Solvent Methanol/water 60% (v/v) Ratio of botanical to native extract 7 to 10:1 Carrier Maltodextrin Residues of pesticides, radioactivity and aflatoxins The raw material to be extracted should meet the limits of controlled substances. 2

3 Specification of Senna Leaves Powdered Extract (>5% Sennosides) Appearance /Odour Brownish to brown extract with characteristic odour Mesh size Not less than 95% thru 80 mesh Identification by TLC Complies to standard Method Corresponding to DAB 10 to 2. Suppl. Purity tests Residual solvent (by GC) Less than 0.05% methanol Loss on drying (2 h at 105 Deg C) Not more than 5% Microbiological Purity Aerobic Bacteria : Not more than 500 cfu/g (Total plate count) Molds and Yeasts : Not more than 100 cfu/g (Total plate count) Pseudomonas aeruginosa/presence : None detected Staphylococcus aures/ Presence : None detected in 1 g Escherichia coli/presence : None detected in 1 g Salmonella Spp/ Presence : None detected in 1 g Assay (Photometric) Method Not less than the stipulated Sennosides content US- Method. 3

4 SECTION II PRODUCT APPLICATIONS Senna as Purgative Drug Senna is valued in medicine for its cathartic properties, especially in habitual constipation. Senna appears to have been used since the ninth or tenth century. Indications and dosage Indications Contra-indications Side effects Atonic constipation. Bowel evacuation for radiological examination. Intestinal obstruction, spastic constipation, electrolyte imbalance, lactation. Nausea, vomiting, skin rashes, fixed drug eruption, Regular use (4 to 12 months) causes colonic atony and mucosal pigmentation (melanosis) 4

5 SECTION III INDIAN MANUFACTURERS * Glaxo India, Mumbai * Cipla Ltd., Mumbai * Mehta Pharmaceutical Pvt. Ltd., Punjab * Kothari Phyto Chemicals International, Tamil Nadu * Hindustan Pharmaceuticals, Punjab * Alchem International Ltd.,New Delhi. * Shashi Phytochemical Industries, Rajasthan. Indian installed capacity Around 100 tonnes per annum 5

6 SECTION IV IMPORT/EXPORT LEVEL 4.1. Imports Nil 4.2. Present export level 150 tonnes per annum PERIOD APRIL 2001 TO MARCH 2002 Country Quantity in kgs Argentina 160 Australia 3650 Brazil 200 Canada 3450 Chile 20 Chinese Taipei 120 China P RP 4 Colombia 10 Cyprus 300 Egypt A RP 190 France 60 German F Rep 150 Hong Kong 100 Israel 2 Italy 274 Japan 8206 Malaysia 20 Mexico 7004 Netherland 10 Russia 6040 South Africa 108 Spain 125 Switzerland 6206 UAE UK 2135 Ukraine 5000 USA

7 SECTION V PRICE DETAILS Basic price Content 10%) Content 15%) Taxes and duties Rs. 750/- per kg. Rs. 1050/- per kg. Extra as applicable 7

8 SECTION VI INDIAN DEMAND Indian formulators of Senna extract include the following Name of the Name of the Use company formulation Allenburys Glaxenna Total sennosides (calcium salts) Calculated as Sennocide B 11.5 mg Alembic Laxatin Sennosides A&B (as calcium salts) 12 m, dioctyl sod. sulphosuccinate 50mg. Alpine Laxsena (Senna extract) Tab. 12 mg Forte Tab. 18 mg. Novartis Pursennidin (with D.O.S.) Purified senna ext. (as calcium salt) 18 mg dioctyl sodium Sulphosuccinate 50 mg Wander Sofsena Purified Senna Extract (as calcium salt) 12 mg) Cipla Senade Standarised senna ext. (sennosides A&B as Calcium salts) 13.5 mg. Franco India Evacuol Karaya gum 3.1 g, sennosides A&B (as calcium salts), 15 mg per 5g, granules. 8

9 Growth rate and Assessment of demand Growth rate Driving Factors As Calcium Sennoside is plant based drug and phyto pharmaceutical and it is a traditional drug (used since 9th or 10th century) and it is produced in selected areas in the world, including India, the product has been traditionally exported from India. Assessment of Indian demand Production level 155 tonnes per annum Domestic Indian consumption level - 5 tonnes per annum Export level 150 tonnes per annum Factors influencing the growth in demand Traditional drug Exports Annual growth rate in percentage - 5%. Annual growth rate in percentage 5 to 6% 9

10 Process conditions SECTION VII BROAD OUTLINE OF MANUFACTURING PROCESS Part of plant used leaves Solvent methanol/water 60% (v/v) Ratio of botanical to native extract 7 to 10:1 Residues of pesticides, radioactivity and the raw material to be extracted should meet the Aflatoxins limits of controlled substances Source of technology * Central Drug Research Institute, (Council of Scientific & Industrial Research) Chattar Manzil Palace, Mahatma Gandhi Marg, Post Box No. 173,Lucknow Plant and machinery equipment and suppliers Reactor Chemitherm Plants & Systems P. Ltd., 30, Anandha Street Alwarpet, Chennai Texel Fabricators Pvt. Ltd., 335, Sidco Industrial Estate, Ambattur, Chennai , Tamil Nadu Filter Fluid Control Equipments 77/574, Mount Road, Chennai Sri Ranga Industries SF, 739, Ramraj Nagar, Goldwins, Coimbatore Dryer Richard Engineering (Bombay) Pvt. Ltd. 10

11 42, IIF, Veerabadran Street Near Valluvar Kottam Nungambakkam, Chennai Steam boiler Ganson Ltd. 645, Anna Salai, Chennai Sri Ranga Industries SF, 739, Ramraj Nagar, Goldwins, Coimbatore Firetech Boilers Pvt. Ltd. No.211, 2nd Cross, 38th Main, B.T.M. Layout 2nd Stage, Bangalore-68 11

12 SECTION VIII RAW MATERIAL REQUIREMENTS, UTILITY AND AVAILABILITY Raw material requirements Basis: One tonne of Calcium sennoside Senna leaves Oxalic acid Citric acid Calcium chloride Conc HCl Methanol 25 tonnes 0.5 tonnes 0.5 tonnes 1.5 tonnes 1.8 tonnes 8.5 tonnes Utility Installed power Fuel 50 H.P. 80 litres Raw material availability Senna plantations are extensively cultivated in Tamil Nadu and are readily available 12

13 SECTION IX GLOBAL SCENARIO Calcium sennoside is a traditional product used as laxative In recent times, Calcium sennoside is reported to be using its market share to natural fibre based products, which are considered to have less side effects. Global supplier include the following Interchem Corp., USA Alcon-Couvreur NV, Belgium Conforma, NV, Belgium Jenssempharma A/S, Denmark Brandeis Intestl France SA, France Sunkyong USA Inc., USA PMC Specialities Group, USA 13

14 SECTION X DISCUSSIONS ON ECONOMIC CAPACITY, PROJECT COST AND PROFITABILITY PROJECTIONS Economic capacity : 9 tonnes Project cost : Rs.76 lakhs Assessment of project cost 1. Land S.No. Description Cost Rs.in lakhs 1.1 Cost of land of one acre at Rs.5.5 lakh per acre\ Cost of levelling, laying internal roads/fencing and 0.55 compound wall Subtotal Building S.No. Description Cost Rs.in lakhs 2.1 Factory building of area 210 sq.m. at Rs.3200/sq.m Non-factory building of area 100 sq.m.at Rs.4500/sq.m. 4.5 Subtotal Cost of Plant & Machinery S.No. Description Cost Rs.in lakhs 3.1 Cost of basic plant and machinery Instrumentation and control Pipelines and valves Structurals for erection 1.00 Subtotal Octroi, excise duty, sales tax, etc.at 12% Packaging and insurance charges (2%) Transportation charges (2%) Machinery stores and spares (2%) Foundation charges (2%) Installation charges (2%) 0.49 Total cost of plant and Machinery

15 4. Technical know-how fees Rs.2.50 lakhs 5. Miscellaneous fixed assets S.No. Description Cost Rs.in lakhs 5.1. Electrification Steam boiler and auxillaries Water storage tank, borewell etc Fuel storage tank Laboratory equipment Office machinery & equipment Material handling equipment, packaging machinery, 0.6 weigh balance, etc Diesel generator Effluent treatment 1.2 Total Preliminary & Pre-operative expenses: S.No. Description Cost Rs.in lakhs 6.1. Preliminary expenses Pre-operative expenses: Establishment Rent rates and taxes Travelling expenses Interest and commitment charges on borrowings Insurance during construction period Other preoperative expenses and deposits Interest on deferred payment - Total Provision for contingency Rs.3.75 lakhs 8. Working capital margin Rs.4.91 lakhs 9. Total project cost Rs.76 lakhs 10. Means of finance (Rs. in lakhs) Promoter's contribution 30 Term loan from financing institutions 46 Total project cost Financial statements 15

16 Cost of production A Variable cost Rs. in lakhs Raw material and utilities Spares and maintenance 1.79 Selling expenses 3.60 Total variable cost (A) B Fixed cost Salaries and wages 6 Interest on term loan and working capital loan Depreciation 4.3 Administrative expenses 2.16 Total fixed cost (B) C. Total cost of production (A+B) D. Selling price per kg. (in Rupees) 800 E. Annual sales turnover 72 F. Net profit before tax (E - C) G. Breakeven point in % 50% 16

17 SECTION XI SWOT ANALYSIS Strength Weakness Opportunity Threat Ready availability of raw material Low indigenous demand Export Substitution possibility 17

18 SECTION XII FACTORS INFLUENCING THE POSITION FOR A NEW INDUSTRY AND RECOMMENDATION Medical practitioners are generally of the view that anthraquinone laxatives should be considered as treatment for constipation as last resort. Senna is a such powerful laxative that it can cause cramping and abdominal distress if not used with caution. Senna tastes awful. Even the herbal medical practioners generally discourage using Senna as a recommended over the counter drug. Senna is certainly an effective laxative but most medical practioners consider two other anthraquinone laxatives namely buckthorn and cascara sagrada to be more gentler and therefore more preferable. Larger doses of Senna can cause diarrhea, nausea and severe abdominal cramping and possibly dehydration. Senna s powerful action means that it should not be used in chronic gastrointestional conditions, such as ulcers, colitis or hemorrhoids. The nursing women should not take Senna. And Senna should never be used for more than two weeks, because over the time, it can cause what is known as lazy bowel and inability to move stool without chemical stimulation. Calcium sennoside essentially represents an export oriented project 18

SEBACIC ACID SECTION I PRODUCT CHARACTERISTICS AND SPECIFICATION SECTION VII BROAD OUTLINE OF MANUFACTURING PROCESS

SEBACIC ACID SECTION I PRODUCT CHARACTERISTICS AND SPECIFICATION SECTION VII BROAD OUTLINE OF MANUFACTURING PROCESS SEBACIC ACID CONTENTS SECTION I PRODUCT CHARACTERISTICS AND SPECIFICATION SECTION II PRODUCT APPLICATIONS SECTION III INDIAN MANUFACTURERS SECTION IV IMPORT/EXPORT LEVEL SECTION V PRICE TRENDS SECTION