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SOFTIGEL IS your iCDMO Softigel by Procaps – Corporate Presentation www.softigel.com
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Page 1: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

SOFTIGEL IS

your iCDMO

Softige l by Procaps – Corporate Presentation www .softigel.com

Page 2: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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

Page 3: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

THIS ISPROCAPS

Softige l by Procaps – Corporate Presentation www .softigel.com

Page 4: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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

Page 5: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

Enjoyable consumer experience as an enabler of Innovation and Growth: Our Business

Page 6: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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

Page 7: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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.

Page 8: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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.

Page 9: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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!

Page 10: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

3. Geographical Footprint.

STRATEGIC LOCATIONS

Page 11: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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

Page 12: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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

Page 13: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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

Page 14: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

6.REVOLUTIONARYTechnologies for

Softige l by Procaps – Corporate Presentation www .softigel.com

enjoyable consumer experience

Page 15: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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

Page 16: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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%

Page 17: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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

Page 18: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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

Page 19: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

Impossible tocounterfeit

Fastabsorption

Elegantappereance

Easy and comfortableTo swallow

for the consumerSOFTGEL BENEFITS

Page 20: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

for the brandSOFTGEL BENEFITS

Preferred dosageform by patients.

Diverse presentations (size, shapes and colors)

Improves profitabilitywhile increasingawareness of yourbrand

Page 21: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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

Page 22: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

Softgels7. BEYOND

Twist Off

M odified Release

Enteric Coated

Enteric Clear

Page 23: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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 .

Page 24: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

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.

Page 25: SOFTIGEL IS youriCDMO · 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. 3 Pharmaceutical

Get the QUALITY, FORMULATIONSCHOICES and SERVICES you demand.

LET’S STAY IN TOUCH!

[email protected]


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