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Solutions Small Molecules Development Drug Substance – new Commercial API Manufacturing

Commercial API Manufacturing

At Aragen, small molecule API manufacturing has been our expertise for two decades, covering all phases from preclinical to commercial. Our philosophy is to not operate just as a service provider; we operate as an equal partner committed to making your API manufacturing project a success. We are proactively ready to tackle any challenges that may arise with a “expect-the-unexpected” mindset.

With a collaborative approach and an unwavering commitment to cGMP standards, Aragen stands uniquely qualified to assist you in delivering a reliable supply of API, built on safe and robust processes. Our extensive capabilities in commercial API manufacturing allow us to seamlessly transition your project from development to scale-up and eventual commercial production. Aragen offers a streamlined technology transfer process, providing consistent support throughout the manufacturing journey, ensuring your project’s success every step of the way.

Hyderabad

Manufacturing Facility – I in Nacharam, Hyderabad: 

Our state-of-the-art manufacturing facility boasts 15 years of excellence in the industry. Designed to meet the highest standards, our facility includes:

  • 7 GMP Blocks: Featuring a total reactor volume of 169 KL, with reactors ranging from 20 L to 6000 L. Our reactors are made of various materials including SS316, SS304, glass lined, Hastelloy, and all glass.
  • Clean Rooms: We have 5 class 100000 clean rooms dedicated to finished product processing, ensuring the highest level of sterility and quality.
  • Supporting Equipment: Our facility is equipped with essential filters, dryers, and powder processing equipment such as multi millers, sifters, and air jet mills.
  • Warehouse Facilities: Featuring multi-level racks and an RLAF facility for precise sampling and dispensing.
  • Power Backup: Equipped with 2425 KVA DG sets and a 100 KVA UPS backup facility to ensure uninterrupted operations.
  • Hydrogenators: Fully automated safety interlocks with maximum operating pressure of 20 bar and capacities of 100 L, 600 L, 1000 L, and 2000 L.
  • Cryogenic Reactors: Two reactors with capacities of 500 L and 4000 L, capable of handling reactions at -80°C using liquid nitrogen.
  • Specialized Reactors: Hastelloy reactors with 200 L and 500 L capacities for fluorination reactions.
  • Thermic Fluid System: PLC-operated system to manage high-temperature reactions up to 200°C and handle water-reactive chemicals efficiently.
  • Distillation Equipment: A falling film evaporator designed for the distillation of heat-sensitive compounds with minimal residence time.
  • Gravity Chromatography Columns: Four large-scale columns ranging from 70 L to 2000 L for the effective separation of isomers and products.

Quality Control Lab: A fully equipped lab including advanced instrumentation, a wet lab, and stability chambers adhering to ICH guidelines.

Description Block No. of reactors No. of Centrifuges No. of Driers Volume
Large Scale Manufacturing

  1. Intermediate Area.
  2. Clean rooms.
  3. Powder Processing.
 Block-A & Block-B 24
09		 10
06		 12
07		 47250 L
19900 L
Pilot Plant & Large-Scale Manufacturing Block-C 20 08 07 43630 L
Kilo Labs R&D Block-D 12 12 03 2313 L
High Pressure & Special Reactions

  1. High Pressure reactions.
  2. Supporting reaction & Work-up.
  3. Column chromatography.
 Block-E 12 03 02 38200 L
Custom Synthesis

  1. Kilo Labs -2 nos.
  2. Pilot Plant Module.
  3. Clean room.
  4. Powder processing area.
 Block-F 21 06 10 17720 L
HPAPI facility G-Block 3 0 1 310 L
TOTAL 7 101 34 42 169,323 L


Certifications /Accreditations :

Visakhapatnam

Our state-of-the-art manufacturing facility is designed to meet the highest standards of quality and efficiency, ensuring we deliver top-notch products to our clients. Here’s a closer look at our capabilities.

S.No Description Block No. of reactors No. of Centrifuges No. of ANFDs No. of Driers Volume
1 Large Scale Manufacturing

  1. Intermediate Area.
  2. Clean rooms –1(OEB-5)
  3. Clean Room-Kilo lab
  4. Powder Processing.
 Block-A1 28 08 04 09 79000L
2 Large scale manufacturing

  1. Intermediate area
  2. Cryo Reaction/TCU
 Block-A2 15 02 03 01 105000L
3 Kilo Labs Block-B 5 03 0 02 1600 L
4 High Pressure & Special Reactions

  1. High Pressure reactions.
 Block-C 3 0 0 0 7000 L
Total 51 51 13 07 12 192,600 L

Salient features:

4 GMP Manufacturing Blocks: Equipped with 51 reactors, including glass lined, Hastelloy, and all-glass reactors, with a total reactor volume of 192.6 KL. Our diverse reactor types enable us to handle a wide range of chemical processes.

Hydrogenators: We have two 1KL and five 5KL fully automated hydrogenators, featuring safety interlocks and a maximum operating pressure of 25 bar, ensuring safe and efficient hydrogenation processes.

Clean Rooms and Cryogenic Reactors

Clean Rooms: Our facility includes 2 clean rooms (Class 100,000) dedicated to the production of finished products, maintaining high standards of cleanliness and quality control.

Cryogenic Reactors: With two cryogenic reactors (2KL and 4KL), we are equipped to handle low-temperature reactions, ensuring precise control over critical processes.

Supporting Equipment and Systems
All supporting equipment like filters, dryers, ANFD (agitated nutsche filter & dryer) with safety interlocks.

Production Streams

3 Production Streams: Our facility supports high, medium, and low volume projects, offering flexibility to meet the varying demands of our clients.

Storage and Handling

Warehouse Facilities: Equipped with a cold storage room (2 to 8° C) and a controlled temperature room (NMT 25° C), along with a 350 KL bulk solvent storage capacity. Our warehouse also features an RLAF facility for the safe sampling and dispensing of raw materials.

Specialized Equipment

Gravity Chromatography Columns: We use two gravity chromatography columns (450mm and 600mm diameter) for the separation of isomers and products, ensuring high purity and quality.

API Processing Capabilities:

Large Scale Manufacturing (Class-100,000):

Module-1: 

  • 2 crystallizers with 1000 L and 2000 L crystallization process capacity followed by filtration, drying and powder processing area (HPAPI).

Module-2:

  • Powder processing area with Micronization/ Milling/ Sifting, Blending and Packing area.

Small Scale Manufacturing (Class-100,000):

  • 100 L and 20 L volume crystallization reactors connected with PLC based Thermic Fluid system (- 50 to 200°C) to maintain precise ramp cooling rate.
  • Filtration, Drying and Powder processing area.

Certifications /Accreditations