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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
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LET’S STAY IN TOUCH!soft ige [email protected]