Softigel by Procaps presentation adjustments

Innovating in Advanced
Softgel Technologies
Take 10 minutes
to get to Know us better...
This is what we do.
About Us
Procaps Group, a diversified collection of Healthcare and
related businesses, including soft-gel capsule
manufacturing, advanced new drug delivery technologies,
and a Pharmaceutical Division with a distribution network
that reaches
countries around the world.
42
Our services and experience are at your disposal.
B2C
B2B
We come from Colombia
Started operations in 1977 in the city
of Barranquilla, Colombia,
pioneering in soft gelatin capsule
production, now considered Latin
America´s major softgel producer,
participating in diverse segments
within the health industry by means
of its Strategic Business Units.
Why Softigel by Procaps?
Latin America's largest softgel encapsulator
Experience with more than
500
36+Years of experience
243+
softgel formulations
8+
Products in Softgels and associated
tech´s launched during 2014
Leading softgel
technologies
11
billion doses of
annual capacity
Partner with top global pharma players, generic companies
in High Regulated Markets, Start-up companies; among many others.
What else?
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
Equiment
& Tooling
Packaging
and Labeling
We integrate and control every inch of the process like no other CMO!
Strong existing customer relationships
due our quality & delivery
Flexibility is our favorite word!
Strategically
Located Sites
San Salvador, El Salvador
Barranquilla, Colombia
Barranquilla, Colombia
Bogotá, Colombia
Bogotá, Colombia
Barranquilla, Colombia
Caracas, Venezuela
Sao Paulo, Brazil
Our Quality Certifications:
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EU GMP Approved
First Latin American manufacturing company for pharmaceutical
products in soft gelatin capsules approved by the United States
Food and Drug Administration (US-FDA)
BASC
Health Canada
ANMAT (Argentina)
ANVISA (Brazil)
MOH (Iran)
Colombian Agricultural Institute
Product Development Services
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.
The development group provides clients with access to:
• Formulation development
• Process development
• CTM manufacturing
• Scale-up services
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. Flexibility for GMO batches
G
Pre-clinical
a
lob
l Re
to r
gula
t t hrough al
y Suppor
l life
c yc
le p
ha
Non GMP batches
Analytical method development
and evaluation
Cleaning residue test
se
s
CTM (Clinical Trial Materials) lots
Pre-formulation
Formulation development
Product Development Services
Pre-formulation
Phases I & II
Formulation development
Analytical method development
and validation
We cover a wide service range of
services along the full lifecycle of a
softgel and other drug delivery
forms, from early development to
large scale commercial supply.
Cleaning residue test
Tech-transfer
Commercial
Phase IV
Line extensions
Scale up services
Reformulations
Process Validation
Labeling & Packaging
Cleaning Validation
Marketing Support
Regulatory Support
G lo
ba
l Re
le
gu la
c yc
e
f
tor y S
i
uppor t t hrough all l
a
ph
se
s
Phase III
Commercial Manufacturing
Fully integrated Pharmaceutical Development
Services (PDS) and commercial manufacturing can
deliver your unique dosage form.
Some of the benefits that Softigel has delivered
through softgel dosage forms include:
• Enhanced bioavailability for low
solubility/low permeability compounds.
• Life cycle management extension for
drug product.
• Low dose/high potency compounds that
guarantee uniformity of dosage.
• Lipid formulations including: improved,
self emulsifying API formulations
Advanced Softgel associated
Technologies for every need.
Meet them here.
Softgel Advantages
• Improved bioavailability of poorly water-soluble and
poorly permeable compounds.
• Containment strategy for the manufacturing of
highly potent compounds.
• Improved content uniformity of low dose
compounds.
• Tamper evident.
• Counterfeiting prevention.
• Suitable for liquid and semisolid APIs.
• Easier to swallow than tablets.
• Improved patient acceptance and preference.
• Many shapes, sizes and colors available for
differentiation.
Facts tell us that Softgels
are the ideal dosage form
• When studying patients´ preference in oral
dosage forms, 71% prefer Oval Softgels, 40%
Oblong Softgels, while only 39% prefer tablets.
• 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
• Oval and oblong are preferred shapes, as well as
translucid colors.
• Consumers are very much interested in taking
variety of softgels.
% ANSWERS
Dosage form
Easy to swallow Fast action Long action
Oval Translucid Softgels
89
72
10
Oblong Translucid Softgels
42
67
30
Gelatin Coated Tablets
23
7
11
2 Piece Hard Gelatin Capsules
19
33
41
Oblong Opaque Softgels
18
16
21
Oblong Tablets
8
6
21
Round Tablets
7
11
19
Gelatin Coated Oblong Tablets
7
3
25
*Survey made during spring 2009 to 300 consumers that bought at department stores
in the cities of Chicago, Lauderdale, Philadelphia, Phoenix and Sacramento.
Question: “Please rank your preference for how to take
your suplementes from most liked to least liked.”
Softgel Capsules
Tablets
Chewable/Gummy
More facts...
Hard-Shell Capsules
Liquids/Tonics/Bever
Powders/Effervescent
Lozenges/Sublinguals
Sprays/Inhales
0
1
2
Least liked
Source: Nutrition Bussiness Journal survey of 11,435 consumers conducted between 3/27/2014 and 4/8/2014
Source: GELITA Symposium: September 2014
3
4
5
Most liked
Knowledge is a critical component in all of our products
Developing with the end in mind, we deliver robust formulations,
The best and unique option
for overcoming challenges when
formulating low solubility and/or
low permeability APIs.
Gelatin coated tablets,
the best way of preventing
counterfeiting and masking
unpleasant tastes and odors.
The only technique available
for fixed dose combinations which
incorporates the benefits of the soft
gelatin capsule dosage form.
Versatile Non-Animal gelatin technology
that provides compatibility with
high pH formulations and a broader
range of fill excipients.
A new solution in chewable
Nutritional Gummies
softgels for inspiring product
formulations that offer immediate
and long lasting results.
pleasant way of taking vitamins
and supplements.
Micro-particle sterile suspensions, vials,
ophthalmics and prefilled syringes.
Suspensions and solutions
manufactured with great precision
We produce both tablets and powders
for pharmaceutical applications.
Release modes
Immediate-Release, Modified-Release,
Controlled Release, Sustained Release,
Extended Release, Delayed Release
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. Vertically
integrated for Softgel Encapsulation, Enteric
Coating & Packaging
Dedicated to hormone specialty
pharmaceuticals that are produced
under the highest standards and very
controlled specifications. Softigel
offers hormone products in softgels,
tablets and G-tabs™.
As well as softgel capsules,
Softigel manufactures other
pharmaceutical forms, such as
syrups, suspensions, creams,
drops and emulsions.
What we are bringing to the Industry
ENJOYABLE
VALUE
Unique formulations, advanced drug
delivery systems that are suitable
for patients. We have designed a
more pleasant way of taking
medication and supplements.
By integrating and controlling every
inch of the process like no other CMO.
Not just in how we work, but in how we do business
we earn strong relationships with quality and service
rather than lock customers in with inflexible contract terms.
FLEXIBILITY
DIFFERENTIATION
We can develop your products
with the quality, choices and service
you demand, as well as
speed, support and value like you’ve
never seen before.
We bring differentiation to your product category
through our robust formulations, our wide
experience in Project managing, assuring that our
customers’ projects are handled efficiently,
providing confidence and accuracy at all stages.
Product Experience
Through our Vertical Integration
Get the quality, formulations,
choices and services you demand.
Let s stay in touch!
[email protected]
@SoftigelProcaps
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