Warehousing:

Neolpharma's Total Quality is an integral concept that covers the cycle from Raw Materials and Active Pharmaceutical Ingredients thru finished product. All the components required for the development of pharmaceuticals are stored under strict conditions to assure their quality;

  • Temperature Control
  • Sampling stations for Raw Materials and API
  • Access controls and security video monitoring for controlled substances

 

Distribution:

Thanks to our location near the Luis Muñoz Marin International Airport,

modern highways, and access to two major seaports, we have extensive

experience and capability for exporting products globally to countries such as:

 

Manufacturing Services:

With the benefit of an R&D area, we are capable of tailoring our technological resources to the benefit of our customers. With an annual 

capacity of 6 Billion  SDU's, we are able to offer manufacturing of:

 

  • Solid dosage products

 

  • Tablets and capsules with

 

                 -Immediate release

 

                  -Controlled or extended release

 

                   -Solid powders

 

  • Controlled substances class II, III and IV

 

  • Hormones

 

  • High Potency products OEB1-3

 

  • Low to high volume production ranges for specialized products

 

  • Manufacturing and packaging of a wide range of products and  dosages packaged in multiple SKU's

 

Packaging:

Our packaging technology includes a wide spectrum of capabilities and features to fit most markets needs:

 

  • Oral solids in bottles (medium and high speeds)
  • Blister packaging with integrated cartoning, including high speeds:

 

            -PVC/Foil, PVDC/Foil, Aclar/Foil

 

            -Cold forming (Alu/Alu)

 

             -Hospital Unit Dose (HUD)

 

             -RSS printing

 

  • Foil pouches (sachets)

 

  • Liquid bottle filling & packaging including nasal spray capabilities
Quality Assurance Services:

 

 

We conduct our operations under two important principles, “Fit for purpose” and “Right the first time”.  Our quality assurance services cover the entire supply spectrum from raw materials, thru manufacturing and to warehousing and distribution:

 

  • Vendor certification

 

  • Raw Material and Packaging components incoming inspection

 

  • Raw Materials analysis

 

  • Finished product analysis

 

  • Retained samples storage and analysis

 

  • Microbiology testing:

 

                       -Raw Materials and Finished goods

 

                       -Purified Water

 

                       -Air and Surface monitoring

 

 

Stability Studies Sample Storage and Analysis:

* Stability programs design

 

* Stability studies for different climatic zone

 

* Analytical methods development

 

* Wide chambers capabilities

 

* Stability studies reports

 

Analytical Equipment and Technology:

 

We offer state-of-the-art analytical technology to support our customers with specialized technical transfer projects and to optimize our processes. All of our computerized analytical equipment are validated and meet the requirements of FDA’s CFR 21 Part 11. Technology for physical, chemical and microbiological analysis includes:

 

  • Chromatography

 

              -Ultra Performance Liquid Chromatography (UPLC)

 

              -High Performance Liquid Chromatography (HPLC)

 

              -Gas Chromatography (GC)

 

  • Spectrophotometry

 

              -Infrared with Fourier transformation (FTIR) for identity testing

 

              -Infrared “Near IR” for identity testing in the incoming RM warehouse

 

              -Ultraviolet (UV) for identity testing and quantification

 

  • Automated Dissolution Baths

 

  • Differential scanning calorimeter

 

  • Isolation hoods with extraction ventilation

 

  • Physical and wet chemistry testing compatible with USP/EP/JP analytical methods and techniques

Copyright © 2017Neolpharma Puerto Rico  All rights reserved. This information - including product information - is intended only for residents of the United States. The products discussed herein may have different labeling in different countries.