Our strength is the development and manufacturing of injectable hospital products where limited competition is expected including:

• First to market opportunities
• Products with development challenges
• Products with manufacturing challenges
• Ready to Use/ Ready to Dilute formulations

In addition, our capabilities include manufacturing complex solid oral dosage forms (eg extended / controlled / modified release products), and ophthalmic suspensions and solutions.

Manufacturing Site:

RK Pharma leased two (215/215A) ex-Pfizer/Wyeth buildings at Pearl River, NY. These buildings have three (3) floors with a built-up area of ~83,000 sq. ft. Features include:

• Segregated and dedicated Manufacturing Suites having flexibility to manufacture multiple products at the same time.
• Utilities having redundancy and backup such as WFI 12,000 liters per day, a total of 10 AHU’s, Generators, Clean Steam, Chillers etc.
• Walk In storage rooms for holding materials at ambient and 2-4°C. Steris tunnel and tray washers (#3), Steris Autoclaves (#5), Compounding Rooms (#4) having multiple SS tanks ranging from 50L – 1000L. All the compounding tanks are connected to SIP/CIP system
• Manufacturing rooms having modular clean room panels, dedicated man/material entry and exit and utility connections.
• Analytical Lab having HPLC’s, UPLC’s, LC/MS, GC/MS, FTIR, Disintegration apparatus etc.
• Microbiology Lab having Sterility test Isolator, KTA for BET test, HIAC particle counters etc.
• 4 dedicated Filling Isolators - Powder, Liquid, Ophthalmic and Combi (vial & syringe) to manufacture sterile products in vials, syringes and bottles.
• The Isolators are designed to handle High Potent Drug product
• Segregated and Dedicated Solid Oral Facility on the 1st Floor to manufacture extended/ controlled/modified release tablets, capsules, liquids and Transdermal patches.