62%

Dosage

forms

A leading

marketer

of advanced

softgel related

technologies.

One of the world’s

largest softgel

producer with

facilities in Brazil,

Colombia, Venezuela

and El Salvador, and

exports reaching more

than 50 countries

worldwide.

Experience with more

that 650 softgel

formulations,

partnering with big

pharma players, generic

companies in high-

regulated markets, start-

up companie; among

many others.

Approved by FDA,

MHRA, ANVISA,

Health Canada, among

others.

PROCAPS at a glance

Everything started in

1977 as an

encapsulating company

for commodities

Our DNA is focused

on innovation.

Our certifications

have supported us to

move along this path.

We have become a

pharmaceutical group in

the B2C business with

presence in 13 countries

and in B2B reaching more

than 50 countries

Our main goal is to bring enjoyable and consumer friendly products to people around the world.

TODAY

40 years later

OUR HISTORY

San Salvador, El Salvador

Bogotá,

Colombia

Caracas, Venezuela

Barranquilla,

Colombia

Sao Paulo, Brasil

+10

Dosage Forms

Fully integrated

product

development Services (PDS) with

Commercial supply

+136 BillionCapsules manufactured

Geographical Footprint

STRATEGIC LOCATIONS

OUR EXPERIENCE COMPLIANCE WITH

NORMATIVE AND QUALITY

TGA AUSTRALIA

INVIMA

ISO 9001

ISO 14001

GMP – ICA

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

COLOMBIA(PROCAPS, Barranquilla)

VENEZUELA(INTERCAPS, Caracas)

BRAZIL

(SOFTCAPS, Sao Paulo)

SOFT GELATIN CAPSULE CAPABILITIES

21 lines of production

13 billion / year.Packaging Capacity:

310 millions

Blister / year

5 lines of

production

2.2 billions / year.Packaging Capacity:

140 millions

Blister / year

5 lines of

production

1.8 billions / year.Packaging Capacity:

50 millions

Blister / year

Enjoyable consumer experience as an enabler of

Innovation and Growth:

OUR BUSINESS

B2C B2B

SOFTIGEL BY PROCAPS CDMO Business Unit

We offer Contract manufacturing and Product

Development Services, supporting healthcare and

related businesses by developing, manufacturing

pharmaceutical products, nutritional supplements,

veterinary formulations and cosmetics in soft

gelatin capsules and advanced delivery

technologies.

SOFTIGEL BY PROCAPSB2B

Model

We study our clients, understand their needs and

turn our company into an extension of their

operations.

We manage more than 50 projects each

year.

ONE TO ONE INTERACTION

Markets SERVED

6 commercialoffices

+50markets

GREAT FLEXIBILITY. Global Expansion.

Leader in Latam

+366

Clients

9 Locations

Serving 50

Countries

+612 products

developed in

softgels

+448

Scientists

and

technicians

5 FDA

ANDA

approvals

.

1st CDMO in

Colombia

with outsourced

Invima approvals

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.

Vertical Integration Driving Innovation

Flexibility is our favorite word!

We integrate and control every inch of the

process like no other CDMO

ENJOYABLE

EXPERIENCE

VALUE

FLEXIBILITY DIFFERENTIATION

As a result, our customers receive

from their consumers high

acceptance and superior

adherence to therapies,

benefit its profitability and

Increase brand positioning.

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.

We adapt to our customers

needs woffering various

options, we develop products

and services with the

speed and support

required.

We bring differentiation

to your product category

through our innovation,

robust formulations

and technology

platforms.

DNAOur

This is our value proposal

BEYOND SOFTGELS… Meet our technologies

Softgels provide the ability to improve the

biopharmaceutical arameters of formulations, also

allowing the adequate delivery of light and oxygen to

sensitive materials like fat soluble vitamins

Since the content is liquid or semisolid, allows the

delivery of oily materials

Soft capsules are a single-unit solid dosage form,

consisting of a liquid or semisolid fill enveloped by one-

piece hermetically sealed elastic outer shell.

Facts show us that softgels are the ideal dosage form

*Survey made during spring 2009 to 300 consumers that

bought at department stores

in the cities of Chicago, Ft. Lauderdale, Philadelphia,

Phoenix and Sacramento.

EASY TOSWALLOW

SOFTGEL

70%

G-TABS

14%HARD

GELATINE

CAPSULE

9%

TABLETS

7%

FAST ACTINGEFFECT

SOFTGEL

72%

HARD GELATINE

CAPSULE

5%

TABLETS

8%

SOFTGEL

55%

G-TABS

20%

SOFTGEL

34%

HARD

GELATINE

CAPSULE

23%

TABLETS

23%

LONG LASTINGEFFECT

Long lasting and rapid action are also

important

characteristics valued by consumers

Easy swallowing is the main reason

for choosing softgels over other

dosage forms.

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.

Consumer Preferences

Consumer Preferences

Pharmaceutical scientists

and marketers should

consider softgels as

alternative dosage forms

when developing new

compounds or considering

life-cycle management of

existing products.

The survey confirms

preferences for

particular dosage forms

and for softgels over

other dosage forms.

1Overall preference was

driven by ease of

swallowing, and softgels

were rated first by the

majority

of respondents.

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.

2

3 4

Source: Advances in Therapy, Volume 17 No. 5

Softgel Derivations

ACCU-FILLDosage

accuracy

GELATIN MATRIXProgrammed release

for softgelsGelatin as a vehicle

for better absorption

Enteric Clear cover, that

protects acid-label API’s

Enteric cover that masks

unpleasant tastes and

odors.

Topical use, exact

dosing.

INTRODUCING

Combining capsules, tablets or pellets within a single, soft

gelatin capsule is now possible.

: A First to Market Technology

Unigel™ (US Patent No. 8,967,989B2) is the only technology available

for fixed dose combinations which incorporates the benefits of the soft

gelatin capsule dosage form and takes it to the next level.

SOME OF THE APPLICATIONS

OF UNIGELTM INCLUDE:

Any combination of the above.

Single or Multiple active ingredients

with different release profiles

Sustained and immediate

release sites.

Multiple active ingredients

with chemical incompatibility

concerns.

Multiple active ingredients were

at least one is a liquid or a semisolid.

Unigel™ Technology addresses every consumer need

PRENATAL CARDIO VISION

CARE

DIGESTIVE

HEALTH

IMMUNE

HEALTH

SLEEP

AID

SPORTS BEAUTY

With UNIGELTM you can combine powerful ingredients in

liquid and solid phase. ALL-IN-ONE SINGLE DOSAGE FORM

Liquid Fase:

•CLA

•Omega-3

•Borage Oil(GLA),

•Evening Primrose Oil

•Argan Oil

Solid Fase:

•Vitamins

•Minerals

•Supplements

•Alpha Lipoic Acid

•Botanical Extracts

•Aminoacids

•Caffeine

•CoQ10

•Hyaluronic Acid

•Biotine

•Collagen

•Olive Oil

•Avocado Oil

•Chia Oil

•Flaxseed Oil

•Coconut Oil

Why

WHY UNIGELTM?

For HEALTH REASONS

Major security: Content

impossible to counterfeit

Faster action

and absorption.

Better adherence: Avoiding

patients to forget taking

two or more different

medications.

Reduces

medication

error

Easy and comfortable

swallowing

.

WHY UNIGELTM?

For the Product

Exact

Dosing

Improved

bioavailability

Avoids

degradation

by oxygen

due to it´s hermetic

sealing

Improves the

risk-benefit

ratio

Reduces costs

while

combining two

or more drug

products in

one single

dose

WHY UNIGELTM ?

For the BRAND

Innovation in

diverse shapes,

sizes and colors

Consumers prefer

and perceive

softgels to be

faster acting than

other dosage formsImproves

consumer

experience by

masking

unpleasant

tastes and odors

Physical appealing

product due to

it´s clear

appearance

Strengthens your brand while also

increasing revenue

G-tabsTM is a Patented technology for

tablets coated with one or two-toned

color gelatin, printed or not printed.

Gelatin Coated TabletsTechnology

Benefits of G-tabsTM include:

• Easy to swallow

• Custom branding

• Preventing counterfeiting

• Tamper-evident

• Unpleasant flavor and odor masking

• Improve stability of photosensitive APIs

• Looks like a softgel

Non-gelatin based shell using

patented polysaccharides

substitution of gelatin. It is a

mixture of vegetable origin,

composed of Carrageenan, starch

and plasticizers

✓ It may be applied in traditional Softgels, G-Tabs™, and

Unigels™.

✓ High Gel melting point and sealing temperature

optimums for semi-solid fills for modified release (up to

70°C)

✓ Improved stability

✓ Conversion from hard-shell capsules

✓ New formulations avoid cross- linking

✓ Compatibility with high pH fill formulations, and a

broader range of fill excipients

• Solid chewable gels are conveniently

administered without water

• Portable dosage form that eliminates messy

liquids

• Pleasant tasting; helps mask tastes and

odors

• Can be formulated in a range of textures

• Offers consumers a variety of formulations

for different therapeutic lines

• Perfect for children and patients who can´t

take regular medication

Convenient, consumer preferred, totally

ingestible, and ideal for children

Chewable SoftgelsTechnology

With a blend of gelatin, sweeteners, flavoring

and colorings, gummies have the versatility to be

molded into literally thousands of shapes. We

have a specialized facility for the production of

gelatin based nutritional gummies. Within this

category we offer gummy formulations for

children as well as nutritional supplements for

kids and adults.

Some Product Ideas:

GUMMYGELS

delivery system

Actives 3 – 10%

•Vitamins

•Minerals

•Herbal extracts

•Proteins

•Omega

Bulk-Sweetener Agent 65- 75%

•Sugar/ Corn Syrup

•Polyalcohols – Sugar free

•Organic Sweetener: Tapioca Syrup,

•Rice Syrup and Org Cane sugar

Water 16 – 18%

Flavor, color, acids

Intensive sweeteners 2 – 4%

Gelling agent 1 – 7%

•Gelatin

•Agar-agar

•Pectin

•Starch

Source: FONA INT. Gummy Cathegory Insight.

Gummy Benefits Active Convenient and

Healthy Product

Innovative

possibilities

Market

opportunity to

differentiate

Consumer

friendly and

appealing

products

Added

value

Alternatives: Non-Animal derived, Non GMO,

Organic, 100% natural, sustainable,

allergen free, sugar free .

GUMMYGELS

delivery system

Other TECHNOLOGIES

Micro-particle sterile

suspensions, vials, and

prefilled syringes.

Suspensions and

Solutions

manufactured

with great precision

Dedicated to hormone specialty

pharmaceuticals that are

produced under the highest

standards and very controlled

specifications.

As well as softgel capsules, Softigel

manufactures other pharmaceutical

forms, such as syrups, suspensions,

creams, drops and emulsions.

Omega 3 High Concentrates

Molecular distillation & natural oil

refinery producing EFA/Omega RM’s for

Rx, nutritional & food industries.

Technology to produce Rx (85%+)

strength concentration.

We produce both

tablets and powders

for pharmaceutical

applications.

Release modes

Immediate-Release,

Modified-Release,

Controlled Release,

Sustained Release,

Extended Release,

Delayed Release .

OTHER

Technologies

* as of January 2017

**This corresponds to products launched in all of Procaps´strategic business units, line extensions, new developments and products

manufactured to third parties by Softigel.

+670 PRODUCTS

DEVELOPED IN

SOFTGEL308

BEING

MANUFACTURED

TODAY

+136BILLION SOFTGELS

MANUFACTURED TO DATE

Significant EXPERIENCE and CAPACITY*

Our cutting-edge facilities house a fully integrated

PDS (Product Development Services) unit, which

covers all product life cycle phases from early

development to commercial in the same plant, using

equipment replication from lab scale, through small

scale GMP batches, until full scale commercial GMP.

For a range of softgel types and other drug delivery forms, from phase

I scale, scale-up and registration, through to large scale commercial

production.

The development group provides clients with access to:

1. Formulation Development

2. Process Development

3. CTM Manufacturing

4. Scale-up Services

5. Minimizing variability in scaled-up batches

6. Flexibility for GMP batches

Product Development SERVICES

• Non GMP batches

• Pre-formulation

• Formulation development

• Analytical method

development and evaluation

• Cleaning residue test

• Line extensions

• Reformulations

• Labeling & Packaging

• Marketing Support

• CTM (Clinical Trial

Materials) lots

• Pre-formulation

• Formulation development

• Analytical method

development and validation

• Cleaning residue test

• Tech-transfer

• Scale up services

• Process Validation

• Cleaning Validation

• Regulatory Support

We 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

Phase IIICommercial

Phase IV

Product Development SERVICES

FACILITIES Overview

BARRANQUILLA SOFTGELFacility Overview

The Barranquilla facility houses a fully integrated

PDS unit and covers all product life cycle phases

from early development to commercial in the same

plant, using equipment replication between non GMP

and GMP.

The development group provides clients with access

to formulation development, process development,

CTM manufacturing, and scale-up services for a

range of softgel types. From Phase I scale, scale-up

and registration, through to large scale commercial

production, the Barranquilla Operations can meet

your development and commercial needs.

Barranquilla Operations, is the Procaps´ flagship

facility and manufactures a full range of soft

gelatine capsules, with specialized capabilities in

controlled release, API combo, non-animal softgels

and high potency products including hormonal

softgels.

Total manufacturing capacity

• Softgel capsules plant: 13B capsules/year

• Hormones plant: 25M capsules/month

Total packaging capacity

• 310 Millions Blisters/year

BARRANQUILLA SOFTGELFacility Overview

At our Pharmix facility located in Barranquilla, we manufacture other drug delivery forms such as:

• Liquids (Syrups, drops, suspensions)• Solids (Tablets, with coating and without coating)• Powders• Hard Capsules• Semisolids (creams and gels)

Primary Packaging• Blistering Technology for:

• Softgels, Hard Capsules and Tablets• Blistering & Bottling for:

• Capsules, Tablets, Liquids, Powders & Creams

BARRANQUILLA PHARMIX Facility Overview

BARRANQUILLA PHARMIX Facility Overview

Liquids 162,000 L monthly

Creams 48,000 kg monthly

Hard Cap 18,000,000 monthly

Tablets 68,400,000 monthly

Solids 45,300 kg monthly

Coating 14,844,000 monthly

The Sao Paulo facility houses a fully integrated PDS

unit and covers all product life cycle phases from

early development to commercial in the same plant,

using equipment replication between non GMP and

GMP.

The development group provides clients with access

to formulation development, process development,

CTM manufacturing, and scale-up services for a

range of Softgel types. From Phase I scale, scale-up

and registration, through to large scale commercial

production, the Sao Paulo Operations can meet your

development and commercial needs.

SAO PAULOFacility Overview

Sao Paulo Operations, is the Procaps

group South America facility and

manufactures a full range of soft

gelatine capsules, with specialized

capabilities in controlled release, API

combo, and high potency products

including API´s controlled softgels.

Total manufacturing capacity

• Softgel capsules plant: 1.8B

capsules/year

Total packaging capacity

• 50 Millions Blisters/year

SAO PAULOFacility Overview

We have the capacity to produce and package more than 2 billion

gelatin capsules of the highest standard of quality.

Total manufacturing capacity

• Softgel capsules plant: 2.2B capsules/year

• 4 Softgel encapsulation lines

Total packaging capacity

• 140 Millions Blisters/year

• 500.000 bottles/month

CARACASFacility Overview

Our cutting-edge molecular distillation

facility allows us to explore an expand line

of products offering different Omega-3 high

concentrates extracts from fish oils,

including botanical extracts from the

Amazon region.

We have an installed capacity of 997 tons

per year for processing Ethil-Esther 55%.

We also manufacture oils FFA and products

with concentrations between 75% and 85%.

OMEGA 3 (Barranquilla)Facility Overview

Raw Material Supply: Peruvian Sources

• Peru is the leading producer of fish oil used for human

consumption at ~90% of global supply

• Anchovy, a sustainable species, is the primary source

— high naturally occurring EPA/DHA levels &

low contaminants.

• Peruvian waters are renowned for their cleanliness

& sustainability thanks to the Humboldt current and

governmental regulations.

• Low contaminants & heavy metals

OMEGA 3 (Barranquilla)Facility Overview

OMEGA 3 Fish Oils Product Portfolio

HIGH EPA

CONCENTRATION

EPA/DHA:

45/10 50/10

50/20 55/5

HIGH DHA

CONCENTRATION

EPA/DHA:

10/50 8/60

10/7012/50

MEDIUM CONCENTRATION

EPA/DHA:

30/20 33/22 35/25 36/24

38/26 35/30

At our sterile facility we manufacture small scale

sterile products, presented in ampoules, jars,

prefilled syringes, for applications in the human body

through different ways of administration:

STERILES (Bogota)Facility Overview

Ampoules, vials, carpules and prefilled syringes

Dropper Bottles

Intramuscular (M)Intravenous (IV)Intradermal (ID)

NasalOphtalmicOptical

Our vial glass manufacturing process facility has the

capacity of producing 6 million ampoules per month and 1.5

million vials in different sizes.

STERILES (Bogota)Facility Overview

Capacities per line

PHARMACEUTICAL

FORMVOLUME UNITS/MONTH

Ampoules 1,2,3,4,5, and 10 ml 6,000,000/Month

Vials 5, 10 and 20 ml 1,500,000/Month

Drops 1,2,5,10,15 and 20 ml 800,000/Month

Prefilles Syr. 0.1 – 0.25 upto 2.0 ml 1,200,000/Month

Sterille powders 10 ml, 20 ml 3,200,000/Month

Specialized in the research,

development and manufacturing of

Nutraceutical Gelatin Gummies. It is

HACCP (Hazard Analisys and Critical

Control Points), INVIMA and GMP

certified since 2006.

This facility counts with the

appropriate technology for the

development and manufacturing of

gelatin based gummies and with a

qualified and specialized staff that

ensures compliance with international

standards.

GUMMIES (Bogota)Facility Overview

PRESEN-

TATION MANUFACTURING CAPACITY

Minibags 4,500,000/ Month

3g Gummies 24,000,000 / Month

Individual

packages3,000 / Month Minimum Lots 1,200 KG

LABORATORIOS LOPEZ (EL SALVADOR)Facility OverviewThe El Salvador Facility became a part of Procaps in

2014. This facility is specialized in the development

and manufacturing of a variety of solids, semi-solids

and liquid forms.

Solid Form 600.000.000

units/year

Liquid Form 8.784.000.000

units/year

Semisolid Forms 2.520.000.000

units/year

BetalacthamicForms3.996.000 powders*

12.000.000 capsules*

• Powders for suspension

• Units/Year

Get to experience our technologies and softgel facilities by taking our new virtual tour

Get the qua l i ty,

f lex ib i l i t y, cho ices

and serv ices

you demand.

Follow us!

www.softigel.com

LET’S STAY IN TOUCH!soft ige l@procaps.com.co