softigel is youricdmo · products if these were available as softgels rather than in their current...
TRANSCRIPT
SOFTIGEL IS
your iCDMO
Softige l by Procaps – Corporate Presentation www .softigel.com
Softigel by Procaps’ Scientific and Technical expertise can deliver innovative technology and products for patients and customers.
LEARN HOW1. Procaps at
a glance2. Softigel isyour iCDMO
4. Our QualityCertifications
5. Product Development
Services
3. StrategicallyLocated sites
6. Revolutionary Technologies
7. BeyondSoftgels
8. OtherTechnologies
9. ValueProposal
THIS ISPROCAPS
Softige l by Procaps – Corporate Presentation www .softigel.com
We work hand-in hand with our customers and develop products that exceed their expectations.
+70 Scientists and technicians in R&D.Devoted teams for client/market.
We employ over 5,000 people across 13 countries.
A leading marketerof advanced-softgel relatedtechnologies.
Our major production Facilities are located in Colombia, Brazil, Venezuela, El Salvador. Our products are
sold & distributed in over 50 countries.
Our Vertical Integration & Flexibility give us greater market reach & customer relevance.
Unparalleled Scientific Expertise: With more formulations, developing more than 50 productsper year.
Procaps is a globalpharmaceutical group,dedicated to delivering innovation, health and nutrition.
1. PROCAPS AT A GLANCE
Enjoyable consumer experience as an enabler of Innovation and Growth: Our Business
Softigel is Procaps' strategic business unit for contract development services, by developing, manufacturing and commercializing
pharmaceutical products, nutritional supplements, veterinary formulations in softgel patented technologies, offering single and
multiple drug dosage systems.
2. SOFTGELyour iCDMO
WHYWe partner with top global pharma players, generic companies in High Regulated Markets, Start-up companies;among many others.
Softigel by Procaps?
One of the world’sLargest softgelcompanies.
Experience with morethan 670 softgelFormulations.
40 + years ofexperience
8 + leading softgelTechnologies.
+ 13 billion dosesOf anual capacity.
CAPABILITIESSoftigel by Procaps
Manufacturing Expertise for oral and steriledosage forms.
Proven Quality System by: US-FDA, MHRA,TGA, Health Canada: among others.
Leading marketer of advanced deliverysystems, with +8 proprietary softgel technologies.
High-potency: Softgel developmentand manufacturing.
Technology Transfers: deep project management, technical, and operational
expertise to support any transfer requirements at all phases.
Product Launches: with +600 products developed in softgels and +50 launched
annually worldwide.
Environmental Health and Safety: deep expertise handling all types of compounds from development to
commercial supply, using a toxicologic classification system for high potent, hormonal and controlled compounds; among others.
Dedicated Hormone Facility.
Pilot Plant: created for pilot batches, trials,and other small-scale preparations, for analytical, stability and packaging purposes.
Packaging Capabilities: from package development to full commercial scale packaging, with modern state-of-the-art
equipment bringing value and flexibility for our customers supply chains.
Package design: we offer a comprehensive rangeof packaging engineering services.
Smart Logistics: we have the ability to support ourclientsЂ needs for shipping, temperature cycling, orpackage integrity studies.
Serialization: capability and equipment forserialized packaging solutions.
Novel Technologies: extensive experience in the development and manufacture of softgel fixed dose combinations, increasing patient compliance, improving
safety and offering a superior consumer experience.
Regulatory Support: for successful product registration in the expected markets.
.
Vertically integrated CDMO: we strive for efficiency by designing
and producing our very own equipment, molds, customized blister and printer tooling, built at
our in-house engineering division called Dismec, much faster than
any other CDMOand at a lower cost.
Capsule printing capabilities: either traditional or in-line.
Project management capabilities.
Strategic/global sourcing.
WHATELSE?
To be even more efficient, we produce our own gelatin, design and fabricate our own equipment and tooling, and manufacture our own packaging and labeling.
Gelatin Raw
Material
Drug Product
Equipment& Tooling
Packaging And
Labeling
Life CycleManagment
ADAPTABILITY is our favorite word!
We integrate and control every inch of the process like
no other CDMO!
3. Geographical Footprint.
STRATEGIC LOCATIONS
4. Our QualityCERTIFICATIONS
Health Canada
FDA
ANMAT (Argentina)
ANVISA (Brazil)
UAE Ministry of Health
COFEPRIS (México)
BASC (Business Anti-Smuggling Coalition)
MHRA
Gelatin, Free of BSE/TSE.
Gelatin, HALAL Certified.
FDA Philippines
TGA AUSTRALIA
INVIMA
ISO 9001
ISO 14001
GMP – ICA
5. Product Development
SERVICESOur cutting-edge facilities house a fully integratedPDS (Product Development Services) unit, whichcovers all product life cycle phases from earlydevelopment to commercial in the same plant, usingequipment replication from lab scale, through smallscale GMP batches, until full scale commercial GMP.
For a range of softgel types and other drugdelivery forms, from phase I scale, scale-up andregistration, through to large scale commercialproduction.
The development group provides clients withaccess to:
1. Formulation Development2. Process Development3. CTMManufacturing4. Scale-up Services5. Minimizing variability in scaled-up batches6. Flexibility for GMP batches
Product Development
SERVICESWe cover a wide range of Services along the full lifecycle of a Softgel and other drug delivery forms, from early development to Large scale commercial supply.
PRE-CLINICAL PHASES I & II
COMMERCIALPHASE IV
PHASE III
• Non GMP batches • Pre-formulation • Formulation development
• Analytical method development and
evaluation • Cleaning residue test
• CTM (Clinical Trial Materials) lots
• Pre-formulation• Formulation
development • Analytical method
development and validation
• Cleaning residue test
• Line extensions • Reformulations
• Labeling & Packaging
• Marketing Support
• Tech-transfer• Scale up services • Process Validation • Cleaning
Validation• Regulatory
Support
6.REVOLUTIONARYTechnologies for
Softige l by Procaps – Corporate Presentation www .softigel.com
enjoyable consumer experience
the consumer preferred dosage form �Please rank your preference for how to take your
supplements from most liked to least liked.�
Source: Nutrition Bussiness Journal survey of 11,435 consumers conducted between 3/27/2014 and 4/8/2014Source: GELITA Symposium: September 2014�
Softgel Capsules
Tablets
Chew able/G um m y
H ard-Shell Capsules
Sprays/ Inhales
Lozenges/Sublinguals
Pow ders/Effervescent
Liquids/Tonics/Bever
SOFTGELS
Facts show us that softgels are the ideal
DOSAGE FORM
It is clear that soft capsules, are more valued to consumers in terms of swallowability and quick effect, and their first choice over other pharmaceutical forms when taking medication.
Easy swallowing is the main reason for choosing softgels over other dosage forms.
Long lasting and rapid action are also important characteristics valued by consumers
EASY TO SWALLOW
LONGLASTINGEFFECT
FASTACTINGEFFECT
SOFTGEL70%
G -TA BS
14%
H A R D
G ELA TIN ECA PSU LE
9%
TABLETS7%
SOFTGEL34%
G -TA BS
20%
H A R D G ELA TIN E
CA PSU LE23%
TA BLETS23%
SOFTGEL72%
SOFTGEL55%
TABLETS8%
HARD GELATINECAPSULE5%
The survey confirm s
preferences for particu lar dosage
form s and for softgelsover other dosage form s.
1O vera ll preference
w as driven by ease of sw allow ing, and
softgels w ere rated first by the m ajority of respondents.
2
Consumers would be interested in various products if these were available as softgels rather
than in their current oral dosage forms and maybe willing to pay a premium
for softgel products.
3Pharmaceutical scientists and marketers should consider softgels as alternative dosage forms when developing new compounds or considering life-cycle management of
existing products.
4
PreferencesCONSUMER
for the productSOFTGEL BENEFITS
RapidBioavailability
Opaque appereance to protect Photosensitive Products
Allows stability of the active principal
Prevents oxygen degradation due to its airtight closure
ExactDose
www .softigel.com
Impossible tocounterfeit
Fastabsorption
Elegantappereance
Easy and comfortableTo swallow
for the consumerSOFTGEL BENEFITS
for the brandSOFTGEL BENEFITS
Preferred dosageform by patients.
Diverse presentations (size, shapes and colors)
Improves profitabilitywhile increasingawareness of yourbrand
INNOVATION, HEALTH& INNOVATION
through our different technologies
Delivering
UnigelTM
Fixed dose combination in softgels for multidoseTherapies.
ChewgelsTM
Chewable softgels as a new solution for kids and
consumers who havedifficulty swallowing
GummygelsTM
Delivering easynutrition with avariety of formulations inNutritional Gummies.
VersagelTM
Versatile softgelfree from animal derivatives
G-TabsTM
Masking unpleasant tastes and odors withgelatin coated tablets
Softgels7. BEYOND
Twist Off
M odified Release
Enteric Coated
Enteric Clear
8. OtherTECHNOLOGIES
D edicated to horm one specia lty
pharm aceutica ls that are produced under the h ighest
standards and very contro lled specifications.
As w ell as softgel capsules, Softigel
m anufactures other pharm aceutica l form s, such as syrups, suspensions,
cream s, drops and em ulsions.
W e produce both tablets and pow ders
for pharm aceutica l applications. Release m odes Im m ediate-Release, M odified-Release, Contro lled
Release, Susta ined Release, Extended Release, D elayed Release .
Micro-particle sterile suspensions, vials, ophthalmics and prefilled syringes. Suspensions and Solutions
manufactured with great precision
O m ega 3 H igh Concentrates M olecular d istillation & natura l o il refinery
producing EFA/O m ega RM �s for Rx, nutritional & food industries. Technology to produce Rx
(85% +) strength concentration .
We know the value chain of a product; from the market, product design, gelatin manufacturing, unique technologies, launches, line extensions and in some cases even reinvention of products.
9. Our DNA: Value PROPOSAL
VALUE
We adapt to our customers needs woffering various options, we develop products and services with the speed and support required.
ADAPTABILITY DIFFERENTIATIONWe bring differentiation to
your product categorythrough our innovation,
robustformulations
and technologyplatforms.
ENJOYABLE EXPERIENCE
As a result, our customersreceive from their consumers high acceptance and superior
adherence to therapies, benefit its profitability and Increase brand positioning.
Get the QUALITY, FORMULATIONSCHOICES and SERVICES you demand.
LET’S STAY IN TOUCH!