Innovative Science from l ab to l aunch
CRAMS
lnd-Swift
Laboratories Limited lml
Ind-Swift laboratories Ltd. (ISLL)
is a USD- 200 million, fast growing active
pharmaceutical ingredient (API) and contract
research and manufacturing services (CRAMS) Company,
based in Chandigarh, North India. ISLL was established in 1995
and is listed on Mumbai and Luxemburg stock exchange.
ISLL has state of the art R & D center, admeasuring 40,000 sq. ft. having 8
synthetic labs, Kilo lab and fully equipped analytical labs supported by over 100
scientists.
ISLL's commercial manufacturing facility at Derabassi, Punjab, has FDA, EDQM, TGA,
PMDA, KFDA and other approvals, 19 manufacturing blocks including a High Potent API
plant, hydrogenation plant and a fully-equipped cGMP pilot plant. The other
manufacturing facilities are for early and advanced intermediates. ISLL has gained
substantial expertise in successfully handling a breadth of chemistries and reagents at lab,
pilot and manufacturing scale.
ISLL- CRAMS offers world class services across early phase drug d evelopment, process
R&D, contract manufacturing to analytical and regulatory services.
The CRAMS business is managed by proactive, flexible and customer-centric team
of experienced scientific and commercial professionals.
We have successful track record of cost efficient and on time delivery of
projects. The team has deep understanding of the global regulatory,
EHS and IP standards and we remain committed to comply
with all the expected requirements. We take pride in our
rapid responsiveness and execution excellence,
leading to "Customer delight"
Reliable
& Preferred
CRAMS
(Contrad Research &
Manufacturin~ Services)
Partner in Providin~
Innovative Pharmaceutical solutions
• Early phase drug development
• Process research, development and technology transfer
• Contract manufacturing
• Custom chemical synthesis
• FTE Model
• Polymorph evaluation and characterization
• Analytical services
• Regulatory submission support (CMC)
Capability and Capacity Matrix
Volumes
Intermediates
API
KSM/RSM
Small
Appropriate cGMP
cGMP
cGMP
Medium
Appropriate cGMP
cGMP
cGMP
Large
Appropriate cGMP
cGMP
cGMP
Some of the Chemistry Capabilities
• Grignard
• Catalytic Hydrogenation
• Chiral Reductions
• Friedel Craft
• Biotransformations
• Diazotization
• Palladium Chemistry
• Witting
• Cyanation
• Dehydrogenation
• Halogenation reactions
• Gewald
• Reductions (LAH, Borane, DMS)
• Reductive Amination
• Low Temp Alkyl Lithium Reactions
• Chemical Resolution
Contract Research
& Manufacturin~
Services
(CRAMS)
ISLL
ct
IS LL-StrateS1i
Grow h EnS1ines
R & D Lab Infrastructure
• Eight state-of-the-art labora tories equipped w ith 32 standard fum ehoods (Kewaune)
• Facility for high p otent molecules development
• Each lab equipped w ith dedicated unit for chilled water circulation, vacuum & inert gas lines
•
6 station parallel synthesizer (Metler Toledo) design ed for inert reactions with ambien t to elevated
temperatures
• Jacke ted glass reactors (cap acity : 0.5 L, 1.0 L, 5.0 L) w ith flush bottom valve, su pported w ith
temperature range of -80°C to + 180°C for plant simulation studies.
• Lab scale basket centrifuge
• Homogenizer (IKA, Germany) for p article size reduction (nanoparticles) with rpm u pto 40,000,
Capacity 150ml
• Flash chroma tography units (Teled yne ISCO) with UV de tector and au tosampler
• Lyophilizer (Virtis, Ben ch top SLC)
Analytical Capabilities & Infrastructure
• Analytical method development, validations and method transfer
• Impurity profiling - synthesis, isolation and characterization
• Stability studies as per ICH guidelines
• Development of sensitive analytical methods for genotoxic impurities
• Complete evaluation and characterization of polymorphs
Range of Modern Analytical Instruments HPLC, UPLC, prep HPLC, GC- HS, GCMS, XRD, AAS, DSC, TGA, LCMS, NMR,
SEM, Ion chromatograph, Polarized microscope
Kilo lab infrastructure
Kilo lab at R & D Facility, Mohali
(Suitable for small Quantities for Intermediates & API)
Hydrogenator
• All glass assemblies
• Cap acity 2 L to 25 L
• Capacities ranging from 20 L to 100 L
(lx100 L, 2x50 L and 2x20 L)
• Pressure upto 25 kg/cm2
• Temperature ran ge: -60°C to+180°C
• Classified area for intermediates and API to run parallel reactions and projects.
• Necessary supporting equipm ents for Filtration, Drying, Sieving, Milling and Micronisation
etc. in class 100,000 area.
GMP Pilot Plant
Pilot Plant Dedicated to CRAMS in commercial Manufacturing Facility, Dera Bassi -------.._
(Suitable for Advance Intermediates & API)
• Over 4.0 KL of reaction volume
• SS316, GLR reactors and Glass assemblies
• Capacities ranging from 20 L to 1000 L
• Temperature range: -80°C to+ 180°C
• Centrifuges, Nutsche filters, Steam tray dryers, Vacuum tray dryers, Multimill, Sifter, Micronizer
• Class 100,000 clean room
Commercial Manufacturing Facility, Dera Bassi
(USFDA, PMDA, TGA, KFDA,
EDQM Approved API Production Facility-IS09001 : 2008, WH O-GMP Approved) - - - - - - - - .
• Spread over 37 acres
• 19 production blocks
• Over 536 KL of reaction volume
• Over 200 SS 316 and GL reactors
• Capacities ranging from 0.02 KL to 25 KL
• Temperature range : -80°C to + 180°C
• Hydrogenation block
•
Capacity range: 0.035 KL, 0.600 KL, 1.2 KL, 1.5 KL
•
Pressure - 20.0 kg/cm2
• Temperature range : -5°C to+115°C
• Centrifuges, Nutsche filters, Steam tray dryers, Vacuum
tray dryers, Multimill, Sifter, Micronizer
• Class 100,000 clean rooms
• Fully equipped QC Laboratory
• Solvent recovery plant (binary, ternary), ETP & incinerators
High Potent - API manufacturing facility
• Approved cGMP facility, Class 100,000 suites
• Occupa tion al exposure limit (OEL) <0.3 flg/m 3/ 8 hr
• Suitable for h a n d ling Sa febridge category-3
products
• Containment throu gh A H U, Pressure Zoning,
Isolators and Personal Protective Equipmen t
• Isolators equipped w ith HEPA filters in supply &
double H EPAfilters at exh au st
• Isolato r s with n egat ive p r essure to avo id
contamination and exposure
• Material flow through Pass b oxes
• A cc re dita ti on s fr om USFDA, EDQM, TGA
&WHOGMP
High Potent facility
Equipment and infrastructure
Reactors
SS316: 1 X 1.5 KL, 1 X 1.0 KL, 2 X 0.25 KL
GA: 1 X 20 L
MSGL: 2 x 0.25 KL
SS316 Isolators: 7
1 Chromtographic Column
Filtration equipments
Centrifuges, sparkler filters
Supporting post production equipments
Vacuum tray dryers, Microniser, Multimill, Sifters,
Blenders Operatin g temperature
ran ge: -15 oc to +130 oc
Confidentiality
We fully appreciate the importance of confidentiality and protection
of intellectual property ownerships
• Global standards practiced for Confidential Disclosure Agreements
• IP ownership and rights clearly defined at project initiation level
• Complete data protection for customers
• Firewalls within organization (need to know basis)
• Non disclosure & confidentiality agreement executed by all employees
Sourcing Capabilities
ISLL has well networked Global SCM setup for efficien t sourcing having
offices in US, China and UK.
Project Management
Excellen ce in project management systems through dedicated certified PMP and 6 Sigma Green
belt Project m anagers exhibiting high standards in international customer communication will
ensure meeting timelines for our partner's projects.
Accreditations and Compliance
ISLL manufacturing facilities are periodically audited by US-FDA, KFDA (Korea), PMDA (Japan),
BSG (Germany), TGA (Australia), EDQM, NIP (Hungary). Our QA-RA department is well capable
of supporting regulatory filing in all geographies such as US. Korea, Japan, EU (EDMF, CEP),
Canada, Australia, China.
Safety, Health and Environment (SHE)
ISLL complies with all regulatory norms for SHE, takes all measures for personal safety and
environmental protection. All manufacturing facilities equipped with ETPs, solvent recovery
systems, scrubber systems, personal protective equipments, pressure suits and Fire fighting
equipments.
lnd-Swift Laboratories Ltd.
Plot No. E-5, Industrial Area, Phase-2,
Mohali - 160055, Punjab, India
Contact Pe rson : Mr. Shailendra Rastogi
GM Business Development (CRAMS)
•
+91 99157 52368
II
+91172 504478o- 83
•
www.indswiftlabs.com/aboutCRAMS.html
•
[email protected]
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