PROCAPS at a glance. Experience with more that 650 softgel formulations, partnering with big pharma players, generic

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1 62% Dosage forms

2 PROCAPS at a glance 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 highregulated markets, startup companie; among many others. A leading marketer of advanced softgel related technologies. Approved by FDA, MHRA, ANVISA, Health Canada, among others.

3 OUR HISTORY Everything started in 1977 as an encapsulating company for commodities 40 years later We have become a pharmaceutical group in the B2C business with presence in 13 countries and in B2B reaching more than 50 countries Our DNA is focused on innovation. Our certifications have supported us to move along this path. TODAY Our main goal is to bring enjoyable and consumer friendly products to people around the world.

4 San Salvador, El Salvador Bogotá, Colombia Barranquilla, Colombia Caracas, Venezuela Sao Paulo, Brasil +136 Billion Capsules manufactured Fully integrated product development Services (PDS) with Commercial supply +10 Dosage Forms Geographical Footprint STRATEGIC LOCATIONS

5 OUR EXPERIENCE COMPLIANCE WITH NORMATIVE AND QUALITY BASC (Business Anti-Smuggling Coalition) MHRA Gelatin, Free of BSE/TSE. Gelatin, HALAL Certified. FDA Philippines TGA AUSTRALIA INVIMA ISO 9001 ISO GMP ICA Health Canada FDA ANMAT (Argentina) ANVISA (Brazil) UAE Ministry of Health COFEPRIS (México)

6 SOFT GELATIN CAPSULE CAPABILITIES COLOMBIA (PROCAPS, Barranquilla) 21 lines of production 13 billion / year. Packaging Capacity: 310 millions Blister / year VENEZUELA (INTERCAPS, Caracas) 5 lines of production 2.2 billions / year. Packaging Capacity: 140 millions Blister / year BRAZIL (SOFTCAPS, Sao Paulo) 5 lines of production 1.8 billions / year. Packaging Capacity: 50 millions Blister / year

7 Enjoyable consumer experience as an enabler of Innovation and Growth: OUR BUSINESS B2C B2B

8 SOFTIGEL BY PROCAPS CDMO Business Unit

9 B2B Model SOFTIGEL BY PROCAPS 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.

10 ONE TO ONE INTERACTION 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.

11 Markets SERVED +50 markets 6 commercial offices

12 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. 1 st CDMO in Colombia with outsourced Invima approvals

13 Vertical Integration Driving Innovation 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. Flexibility is our favorite word! We integrate and control every inch of the process like no other CDMO

14 FLEXIBILITY We adapt to our customers needs woffering various options, we develop products and services with the speed and support required. DIFFERENTIATION We bring differentiation to your product category through our innovation, robust formulations and technology platforms. DNA Our This is our value proposal VALUE 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. ENJOYABLE EXPERIENCE As a result, our customers receive from their consumers high acceptance and superior adherence to therapies, benefit its profitability and Increase brand positioning.

15 BEYOND SOFTGELS Meet our technologies

16 Soft capsules are a single-unit solid dosage form, consisting of a liquid or semisolid fill enveloped by onepiece hermetically sealed elastic outer shell. 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

17 Facts show us that softgels are the ideal dosage form HARD GELATINE CAPSULE 9% TABLETS 7% SOFTGEL 55% TABLETS 8% G-TABS 14% HARD GELATINE CAPSULE 5% SOFTGEL 70% EASY TO SWALLOW FAST ACTING EFFECT SOFTGEL 72% HARD GELATINE CAPSULE 23% TABLETS 23% LONG LASTING EFFECT G-TABS 20% SOFTGEL 34% *Survey made during spring 2009 to 300 consumers that bought at department stores in the cities of Chicago, Ft. Lauderdale, Philadelphia, Phoenix and Sacramento. 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

18 Consumer Preferences 1 Consumer Preferences The survey confirms preferences for particular dosage forms and for softgels over other dosage forms. 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 Overall preference was driven by ease of swallowing, and softgels were rated first by the majority of respondents. Pharmaceutical scientists and marketers should consider softgels as alternative dosage forms when developing new compounds or considering life-cycle management of existing products. Source: Advances in Therapy, Volume 17 No. 5

19 Softgel Derivations Topical use, exact dosing. Enteric cover that masks unpleasant tastes and odors. Enteric Clear cover, that protects acid-label API s ACCU-FILL Dosage accuracy GELATIN MATRIX Programmed release for softgels Gelatin as a vehicle for better absorption

20 INTRODUCING : A First to Market Technology Combining capsules, tablets or pellets within a single, soft gelatin capsule is now possible. 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.

21 SOME OF THE APPLICATIONS OF UNIGEL TM INCLUDE: 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. Any combination of the above.

22 Unigel Technology addresses every consumer need PRENATAL CARDIO VISION CARE DIGESTIVE HEALTH IMMUNE HEALTH SLEEP AID SPORTS BEAUTY

23 With UNIGEL TM 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 Olive Oil Avocado Oil Chia Oil Flaxseed Oil Coconut Oil Solid Fase: Vitamins Minerals Supplements Alpha Lipoic Acid Botanical Extracts Aminoacids Caffeine CoQ10 Hyaluronic Acid Biotine Collagen

24 Why

25 WHY UNIGEL TM? For HEALTH REASONS Major security: Content impossible to counterfeit Easy and comfortable swallowing. Better adherence: Avoiding patients to forget taking two or more different medications. Faster action and absorption. Reduces medication error

26 WHY UNIGEL TM? For the Product Improved bioavailability Exact Dosing Reduces costs while combining two or more drug products in one single dose Avoids degradation by oxygen due to it s hermetic sealing Improves the risk-benefit ratio

27 WHY UNIGEL TM? For the BRAND Consumers prefer and perceive softgels to be faster acting than other dosage forms Innovation in diverse shapes, sizes and colors Physical appealing product due to it s clear appearance Improves consumer experience by masking unpleasant tastes and odors Strengthens your brand while also increasing revenue

28 Gelatin Coated Tablets Technology G-tabs TM is a Patented technology for tablets coated with one or two-toned color gelatin, printed or not printed. Benefits of G-tabs TM include: Easy to swallow Custom branding Preventing counterfeiting Tamper-evident Unpleasant flavor and odor masking Improve stability of photosensitive APIs Looks like a softgel

29 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

30 Chewable Softgels Technology 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

31 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:

32 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

33 GUMMYGELS delivery system 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. Source: FONA INT. Gummy Cathegory Insight.

34 Other TECHNOLOGIES

35 OTHER Technologies 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. Micro-particle sterile suspensions, vials, and prefilled syringes. Suspensions and Solutions manufactured with great precision 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.

36 Significant EXPERIENCE and CAPACITY* 308 BEING MANUFACTURED TODAY +670 PRODUCTS DEVELOPED IN SOFTGEL +136 BILLION SOFTGELS MANUFACTURED TO DATE * 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.

37 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: 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 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.

38 Product Development SERVICES Pre-clinical Phases I & II 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. Commercial Phase IV Phase III

39 FACILITIES Overview

40 BARRANQUILLA SOFTGEL Facility 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.

41 BARRANQUILLA SOFTGEL Facility Overview 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

42 BARRANQUILLA PHARMIX Facility 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

43 BARRANQUILLA PHARMIX Facility Overview Liquids Creams Hard Cap Tablets Solids Coating 162,000 L monthly 48,000 kg monthly 18,000,000 monthly 68,400,000 monthly 45,300 kg monthly 14,844,000 monthly

44 SAO PAULO Facility Overview 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.

45 SAO PAULO Facility 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

46 CARACAS Facility 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 bottles/month

47 OMEGA 3 (Barranquilla) Facility 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%.

48 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

49 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

50 STERILES (Bogota) Facility Overview 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: Ampoules, vials, carpules and prefilled syringes Intramuscular (M) Intravenous (IV) Intradermal (ID) Dropper Bottles Nasal Ophtalmic Optical

51 STERILES (Bogota) Facility Overview Our vial glass manufacturing process facility has the capacity of producing 6 million ampoules per month and 1.5 million vials in different sizes. PHARMACEUTICAL FORM Capacities per line VOLUME 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 upto 2.0 ml 1,200,000/Month Sterille powders 10 ml, 20 ml 3,200,000/Month

52 GUMMIES (Bogota) Facility Overview 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 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. PRESEN- TATION Minibags 3g Gummies Individual packages MANUFACTURING CAPACITY 4,500,000/ Month 24,000,000 / Month 3,000 / Month Minimum Lots 1,200 KG

53 LABORATORIOS LOPEZ (EL SALVADOR) Facility Overview The El Salvador Facility became a part of Procaps in This facility is specialized in the development and manufacturing of a variety of solids, semi-solids and liquid forms. Solid Form units/year Liquid Form units/year Semisolid Forms units/year BetalacthamicForms powders* capsules* Powders for suspension Units/Year

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

55 G e t t h e q u a l i t y, f l e x i b i l i t y, c h o i c e s a n d s e r v i c e s y o u d e m a n d. L E T S S TAY I N TO U C H! softigel@procaps.com.co Follow us!