Digwal
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Digwal, India

Piramal Pharma Limited, Digwal Village, Kohir Mandal, Sangareddy District, Telangana 502321, India

  • Rajiv Gandhi International Airport, Hyderabad
  • Driving Distance: 69 miles (1 hour 40 min)

Development and Commercial launches of API and Advanced Intermediates

Piramal’s Digwal facility offers services for developing and commercial manufacturing of APIs (NCEs & Generics) and key intermediates. This facility has three manufacturing areas with 12+ multi-purpose production blocks. It has a total volumetric capacity of over 750 kL, housing 245 reactors. The facility has received regulatory accreditations from USFDA, EDQM, AIFA, and KFDA.

Featured Services

API Development

This facility offers services for process and route selection and develops processes for GMP scale-up. It can also manufacture GMP batches ranging from grams to hundreds of kilograms

API Development

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Clinical and Commercial Manufacturing

  • Production Area 1 features 5 multi-purpose production blocks for API/Intermediate production with class 100,000 clean rooms and a dedicated space for vitamin products.
  • Production Area 2 comprises 7 multi-purpose production blocks similarly equipped, including an exclusive block for intermediates and a hydrogenation block capable of high-pressure operations.
  • Production Area 3 houses an Anaesthetic API plant catering to the critical care segment in hospital generics.

Clinical and Commercial Manufacturing

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API Development

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API Development

This facility offers services for process and route selection and develops processes for GMP scale-up. It can also manufacture GMP batches ranging from grams to hundreds of kilograms

Clinical and Commercial Manufacturing

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Clinical and Commercial Manufacturing

  • Production Area 1 features 5 multi-purpose production blocks for API/Intermediate production with class 100,000 clean rooms and a dedicated space for vitamin products.
  • Production Area 2 comprises 7 multi-purpose production blocks similarly equipped, including an exclusive block for intermediates and a hydrogenation block capable of high-pressure operations.
  • Production Area 3 houses an Anaesthetic API plant catering to the critical care segment in hospital generics.

Site Capabilities

  • Custom Synthesis

  • Route Scouting

  • Process Development and Optimization

  • Analytical Capabilities

Custom Synthesis

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Custom Synthesis

The facility offers custom synthesis capabilities including heterocyclic synthesis with enzyme-assisted kinetic resolution, heterogeneous catalysis (Pd/C, Pt/C, Pt/ Al2O3), metal hydride reduction, borane chemistry, stereo-selective synthesis, and troubleshooting in plant operations. It also covers common chemistries such as esterification, cyclizations, and protection/de-protection reactions.

Route Scouting

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Route Scouting

Identifying and selecting IP-compliant, cost-effective, commercially viable, safe, and environmentally friendly routes for NCEs and Generic APIs.

Process Development and Optimization

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Process Development and Optimization

Developing, optimizing, and validating robust processes for NCEs, RSMs/KSMs, intermediates, and APIs.

Analytical Capabilities

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Analytical Capabilities

Developing, qualifying, validating, and conducting stability studies for analytical methods.

Manufacturing Expertise

Manufacturing Expertise

Proven history of backing complex chemistries and offering analytical services, along with dedication to continuous process improvement for our strategic partners.

End-to-End Integrated Solutions

End-to-End Integrated Solutions

Ability to support your drug candidate through its discovery > clinical development > commercialization.

Economies of Scale

Economies of Scale

Flexibility to expand & back-integrate KSM/RSM and API to meet your manufacturing needs.

Quality as Culture

Quality as Culture

Embracing a culture of quality, we integrate rigorous quality checks and balances throughout our operations, ensuring consistent and exceptional product quality. Our teams are dedicated to upholding the highest quality standards at all stages of the development process.

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Digwal provide good and reliable service with a high level of technical expertise.

Biotech, Ireland

I'm pleased with the overall project operations facilitated by the site.

Pharma, UK

Piramal is a trustworthy partner. Keep doing good work.

Foundation, Switzerland

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Digwal Facility : Timeline of Milestones

2024
1988

Greenfield Project (Blocks A,B,C & D operational)

2024
1991-92

Upgraded and expanded adding 2 New blocks (E & F)

2024
2000-02

Expanded to add 1 new block and QA & QC building

2024
2005-06

Expanded to add H Block

2024
2016-17

Expanded to add multiple new blocks and Kilo lab

2024
2019

Expansion of Quality building

2024
2022-23

Expanded to add a new FG warehouse

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Discovery & Route Scouting

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