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Fermenta Biotech Ltd Information
1.
2. DIL GROUP GENESIS AND BUSINESS TREE
1951: International Franchisees Ltd.
Toll mfg –Pharma& Cosmetic Industry
Founder -Late Dr. D.V.K. RajuPhD, UK
1953 : Biological Evans Ltd. (now Biological E Ltd.)
1969 : Uni-Sankyo Ltd. (first Indo-Japanese JV)
1963 : JV with Philips Dupharname changed to DupharInterfranLtd
Manufacturing and Marketing of Pharmaceutical Products
1980 : Duphartaken over by Solvay
1976 -Listed on Bombay Stock Exchange
Solvay Pharmaceutical becomes our JV Partner
1986 -Founded FermentaBiotech Ltd
1999-2002 : Demerger of PharmaBusiness in favor of Solvay
Solvay Pharmaceutical becomes our premier client
Name changed to DIL Ltd.
3. BUSINESSDIVISIONS
FBL business activities are divided into 3 major focus areas, each supported by a research based approach.
Biotech
Environmental Life Sciences
APIs
APIs:
Niche products with value addition.
e.g. Vitamin D3 and Phenyramidol
Biotech:
Novel Enzyme products for pharmaceutical and fine chemical industry.
e.g. Enzyme for antibiotic synthesis.
Environmental Life sciences:
Products and services for various environmental solutions.
e.g. Sewage treatment / lake bioremediation / Oil sludge remediation.
4. OVERVIEW
•Core Area of Business API’s, Intermediates & Biotechnology Products
•Incorporation July, 1986
•Manufacturing facilities 1) Kullu-Himachal Pradesh (North of India) 2) Dahej-Gujarat (West of India)
•Regulatory compliances cGMP Compliant Facility
•ManpowerQualified & experienced pool of 436 personnel
•Manufacturing Team Kullu-238 personnel
•Manufacturing Dahej–127 personnel
•Head Office : Thane (Mumbai)
6. Cholecalciferol(Vitamin D3 crystalline) CAS No. : 67-97-0
Each gram contains 40 million IU of Vitamin D3
Certifications :
•EDQM (COS)
•FAMI QS
•Halal
•Kosher
•WHO-GMP
•HACCP
•ISO 9001: 2008
•BS OHSAS 8001:2007
•ISO 14001: 2004
VITAMIN D3
Pharmacopeias:
Matches EP, USP, FCC & IP
•Vegetarian Certificate From American And European
Regulatory Submissions:
US DMF filed
Canadian DMF Filed
7. FBL VITAMIN D3 INTRODUCTION
•Only Manufacturer in India, among top 2 producers worldwide
•Manufacturing for more than five decades
•Obtained Technology from Solvay Pharmaceuticals, Netherlands
•Supplying to more than 350 customers both Domestic and International.
•More than 95% market sharein the Indianmarket.
8. VITAMIN D3 40 MIU
•Glass Ampoules:
Packing in 10gm/100gm Glass ampoules under vacuum
•Aluminum Containers:
Packing in 250gm /1Kg Aluminum containers under Argon Gas
1
Kg
250
gm
100
gm
10
gm
9. VITADEE VITAMIN D3 100 CWD
•Vitamin D3 100 CWD variants VITADEE CWD /DS and VITADEE CWD / MS grades
•Each gram of product contains 100,000 IU/g of Vitamin D3.
•Used in food / nutraceuticalapplications
•Product forms uniform dispersion in water.
•Aligned towards the products most commonly used currently by the industry
•Product complies Ph. Eur. and DMF to be available soon
•Packed Under Nitrogen in 1, 5, 10 and 20 kg Aluminium Bags.
10. CHOLECALCIFEROL SOLUTION 1MIU PH.EUR /USP
•Available in strengths of 1 MIU / gm or 4 MIU / gm
•Used in food / nutraceuticalapplications
•Available in corn oil / Arachisoil as base
•Packed under inert gas in 1Kg and 10Kg Aluminum bottles.
11. VITAMIN D3 RESIN OILY FEED GRADE
•Available in 2 / 4 / 5 / 10 / 15 MIU gm concentrations
•Used for animal feed premix / blends manufacturing
•Available in soyabean / sunflower oil as base
•Packed in 1 kg / 10 Kg Aluminum containers
12. VITAMIN D3 500 FEED GRADE POWDER (500,000 IU/GM)
•Available as white –yellowish free flowing powder with strength of 500,000 IU / gm
•Used for animal feed, dry blends manufacturing
•Packed in 25Kg LDPE lined kraftpaper bags and 25 Kg LDPE in carton box.
25
Kg
13. •Total Plot area of the Kullufacility : ~ 14170 m2 (Approx.)
•Total built up area (API facility) : ~ 3900 m2 (Approx.)
MANUFACTURING FACILITY DETAILS
BUILDINGS AND FACILITIES
14. MANUFACTURING SITE INFORMATION
•TheSitehasdedicatedManufacturingBlocksfor
–Biocatalysts
–API’s/Intermediates(Area~3900m2)
•TheAPIs/IntermediateBlockcontains3separateProductionsPlants:
–Plant1:DedicatedplantforManufacturingofCholecalciferol
–Plant2:MultipurposePlantforManufactureofAPIs/Intermediates
–Plant3:DedicatedplantforManufactureofActivatedDimethicone
•Kosher , Halal certified and WHO GMP certified
•Strict adherence to Safety, Health & Environment (SHE) policy
Kullu, HimanchalPradesh
15. BUILDINGS AND FACILITIES
•Total Plot area of the Dahejfacility : ~ __________ m2 (Approx.)
•Total built up area (API facility) : ~ _________ m2 (Approx.)
16. MANUFACTURING SITE INFORMATION
•TheSitehasdedicatedManufacturingBlocksfor
–Biocatalysts
–API’s/Intermediates(Area~______________m2)
•TheAPIs/IntermediateBlockcontains3separateProductionsPlants:
–Plant1:DedicatedplantforManufacturingofCholecalciferol
–Plant2:MultipurposePlantforManufactureofAPIs/Intermediates
–Plant3:DedicatedplantforManufactureofActivatedDimethicone
•Kosher , Halal certified and WHO GMP certified
•Strict adherence to Safety, Health & Environment (SHE) policy
Dahej, Gujarat