11
Highly Potent Capabilities Copyright by Procaps S.A 2021 Compound
| Date post: | 10-Jan-2023 |
| Category: |
Documents |
| Upload: | khangminh22 |
| View: | 0 times |
| Download: | 0 times |
Highly Potent
Capabilities
Copyright by Procaps S.A 2021
Compound
Highly Potent Compound Capabilities Copyright by Procaps S.A 2021
About Procaps GroupProcaps Group is a Pharmaceutical Group dedicated to delivering health and nutrition.
A leading Marketer of advanced softgel related technologies.
Our Vertical Integration allows us to o!er end-to-end solutions across the value chain.
Global distribution in over 50 countries.
Deep Scientific Expertise with more than 500 formulations and 50 new lanuches per year.
+70 scientists and Technicians in our R&D Team.
8 facilities of advanced sofgel related technologies.
We work hand in hand with our Customers thinking B2C and acting B2B.
We employ over 5,000 people across 13 countriesin Latin America.
Leading Regional PharmaceuticalPlayer with Global Reach
Attractive Rx and OTC marketpositions in Colombia, CentralAmerica and the Andean Region.
Prescription drug pipeline currently includes 133+ new products to be launched during 2020-2022.
#8 in the region in which Procapsoperates with 4.2 prescriptions per minute.
Ranked #1 in the last two years by IMS(1) for new prescription drug launches in Colombia and El Salvador.
Global reach through leading Softgel CDMO business and global partnerships.
Significant and successful new market entry experience,both organically and via M&A.
OTC, supplements and generic products pipeline currently includes more than 120 new consumer healthcare brands and 320 new products due to go-to-market during 2020.Strong focus on personal health
and wellbeing through improved delivery technologies with a portfolio of ~220 OTC and supplement products across 100+ brands.
+133
#8
#1
320
~220
Highly Potent Compound Capabilities Copyright by Procaps S.A 2021
Procaps Group Business structured enable marketFocus and Innovation
B2C LATAM
B2B GLOBAL
Highly Potent Compound Capabilities Copyright by Procaps S.A 2021
Procaps has the capability to handle highly potent compoundshaving within its portfolio the following:
Our areas are equipped with the procedures infrastructure equipment; HVAC system and Personal Protection equipment to work with highly potent drugs as:
Toxicological Risk Management, including the development of a Risk Assessment Methodology, to prioritize and define critical toxicological risks.
Strict containment systems in all risk operations.
Closed systems, direct or protected connections between equipment.
Anti-return extraction air system and HEPA filtration in all risk operations.
Extraction system located at the point of exposure in all risk operations.
Process controls to avoid cross-contamination
Establishing procedures and practices for operations.
Workers training in procedures and practices for operations with highly potent drugs.
Personal protective equipment definition according the activity to be performed, i.e self-contained air respirator or powered air-purifying respirator (PAPR), Anti fluid safety protective coveralls, identification bracelet, safety shoes, gloves, mask, safety glasses.
Periodic medical control of the personnel.
We have a Pharmaceutical Chemist, Master in Toxicology, responsible for classifying APIs.
Highly Potent Compound Capabilities Copyright by Procaps S.A 2021
Procaps has the capability to handle highly potent compoundshaving within its portfolio the following:
More than 60 Highly Potent Drugs within the more than 170 Active Pharmaceutical Ingredients (APIs) that are used in the development and operations areas.
Currently, more than 40% of the products under development contain at least one Potent or Highly Potent Drugs.
Procedures to introduce and handle the Potent or Highly Potent Drugs in our areas: From API reception to product dispatch. This includes a system to classified all the APIs in four classes according to its toxicity and potency, which was developed following Safebridge Consultant classification systems. In all cases, the aim is to guarantee patients and personnel protection.
Our areas are equipped with the infrastructure, equipment, HVAC system and Personal Protection equipment to work with highly potent drugs.
More than 40 year of experience working on Soft gelatin capsules, which o!er an extra protection of the patients, because soft gelatin capsule avoid patient exposition to the API during the dossage, which is not possible in other dosage form as: tablets and liquids
Separated facilities to manufacture soft gelatin capsules with sex hormones and contraceptive APIs.
60
4040%
API
High Potent Compound Capabilities Copyright by Procaps S.A 2021
Softigel is your
i-CDMO
Copyright by Procaps S.A 2021
Thinking B2C Acting B2BGenerating ideas and creating solutions based on Customer knowledge.
Softigel is an i-CDMOIntegrated Contract Development Manufacturing Organization:
DevelopmentManufacturingAnalysisRegulatoryClinical
Highly Potent Compound Capabilities Copyright by Procaps S.A 2021
Softigel by ProcapsCapabilities
Manufacturing expertise for oral and sterile dosage forms.
Proven Quality System by: US-FDA, MHRA, TGA, Health Canada: among others.
Highy-Potent: Softgel development and manufacturing.
Leading marketer: of advanced delivery systems, with +8 proprietary softgel technologies.
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.
Dedicated Hormone Facility
Environmental Health and Safety: deep expertise handling all types of compounds from development to commercial supply, using a toxicologic classification system for highly potent, hormonal and controlled compounds; among others.
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 o!er a comprehensive range of packaging services.
Smart Logistics: we have the ability to support our clients’ needs for shipping, temperature cycling, or package integrity studies.
Highly Potent Compound Capabilities Copyright by Procaps S.A 2021
Capsule Printing Capabilities: either traditional or in-line.
Highly Potent Compound Capabilities Copyright by Procaps S.A 2021
Softigel by ProcapsCapabilities
Serialization: capability and equipment for serialized packaging solutions.
Novel Technologies: extensive experience in the development and manufacture of softgel fixed dose combinations, increasing patient compliance, improving safety and o!ering a superior consumer experience.
Regulatory Support: for succesful product registration in the expected markets and to support CMC documents preparations for NDAs and ANDAs and also all the post approval activities (anual product reviews: FARs, PAS, CBE, etc)
Vertically Integrated CDMO: we strive for e"ciency 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 CDMO and at a lower cost.
Project Management capabilities.
Strategic Global Surcing
+400 specialists in our R&D Department.
As of Jan 2021 we have 74 Portfolio Patents.
