We manufacture, supply and distribute commercial formulations from our facilities in UK and India for Oral Solids and Lexington, USA for Sterile Injectables. We are a trusted manufacturing partner to leading biotech, small and virtual pharmaceutical companies as well as mid-size and big pharmaceutical companies. Our scalability is defined from Pilot level to Commercial level to serve customers at every stage of drug lifecycle from manufacturing perspective. We leverage our Global network of manufacturing sites and are successful in supplying commercial formulations to the US, Europe, Japan and Asia Pacific markets.

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Oral Solids

Our manufacturing facilities are located in Morpeth, UK and Pithampur, India which are USFDA ,UK MHRA accredited. These sites offer a wide spectrum of oral solids such as conventional tablets, modified release formulations, press coated tablets, hard gelatin capsules etc. We specialize in hormonal formulations that are manufactured in dedicated and segregated suite. Our extensive experience along with skilled personnel has led us successful supply of commercial formulations to the North America, Europe, and Asia Pacific markets.

Dose Forms Handled

  • Tablets (Film Coated/IR/ER/MR)
  • Hard Gelatine Capsules (Powders,Granules & Pellets)
  • Special solid dosage forms
    • Press coated tablets (Tablet in Tablet)
    • Bi-layer tablets
    • Controlled release solids (Matrix)
    • Hormonal Products

Process knowledge and expertise in solid dose operations

  • Wet and dry granulation
  • Roller compaction
  • Fluid bed processing and drying
  • Compression and encapsulation
  • Film coating
  • Press coating technology
  • Containment suite for Hormonal Products (Oral Contraceptive Pills)
  • High speed blister packaging and bottle packaging capability
  • Dedicated low RH block, can handle upto 20% RH

Hormonal Products

  • Dedicated and segregated hormonal manufacturing suite and packaging capabilities
  • Extensive experience (40+ years) of handling hormonal products
  • Experienced in Hormonal product development and technical transfer
  • Experienced in handling a broad range of hormonal APIs

Sterile Injectables

Our Sterile Manufacturing facility located in Lexington, Kentucky in the USA offers cGMP manufacturing of a wide range of injectable products. We combine individualized service with unparalleled speed and flexibility to manufacture parenteral drug products in liquid and lyophilized dosage forms. Unique mobile isolator technology within our 22,000 square foot state-of-the-art FDA approved sterile manufacturing facility ensures product containment for potent and cytotoxic compounds products while providing an aseptic manufacturing environment.

Product Experience

  • Sterile Solutions & Suspensions (Aqueous/ Non – aqueous suspensions)
  • In-situ Salt Formations
  • Nanoparticles & Liposomes
  • Stable emulsions
  • Lyophilized Products

Our Services

  • Process Development & Optimization
  • Clinical and Commercial manufacturing of liquid and lyophilized formulations
  • Pre-Clinical to Phase III Manufacturing for:
    • Animal Safety/Toxicity Studies
    • Human Clinical Products
    • Veterinary Products
  • Development and manufacture of potent drug products
  • Pilot-Scale Manufacturing: Aseptic and Non-Aseptic
  • Sterile and ADC Fill/Finish
    • Vials from 2 – 50 mL
    • Dispensing volume as low as 0.5 mL up to 50 mL
  • Parenteral Lyophilization
    • Vials from 2 – 50 mL
    • Dispensing volume as low as 0.5 mL up to 50 mL
  • Terminal Sterilization

Lyophilization

  • Clinical Scale and Scale Up Development
  • We use a LyoStar™II and a LyoStar™III R&D freeze dryer to develop lyophilized formulations that are based on robust and cost-efficient processes.
  • Our rapid-response formulation team has experience in screening effective combinations of solvents (both aqueous and non-aqueous), buffers, bulking agents, and lyo/cryo-protectants. This experience leads to a robust final product that has low residual moisture/solvent, forms a solid and attractive cake, reconstitutes readily and completely, and resists physical and chemical degradation.
  • Using our lab-scale freeze dryers, Piramal's formulation team develops compounding processes and lyophilization cycles that can be successfully and readily transferred to our cGMP production scale freeze dryer.

Capacity

  • Clinical scale production of lyophilized products centers around the 48 square foot Hull lyophilizer within our sterile manufacturing facility.
  • Our freeze dryer is fully integrated with the state-of-the-art, isolator-based automated filling lines. The lyophilizer chamber can accommodate up to 15,000 units per cycle depending on vial size.
  • Hull Capabilities
    • Serum Vial Capacity (Number of Vials Processed)
    • Vial SizeApproximate Full Load
      3 mL15,000
      5 mL9,000
      10 mL7,500
      20 mL4,500
      30 mL3,200
      50 mL2,300

Form Fill Seal

We offer Form Fill Seal (FFS) service from our Pithampur, India facility. We have an experience in handling Eye/Ear drops and contact lens cleaning solution for unit/multi dose vials. The Pithampur site is well equipped with Weiler filling machines for accurate filling. One of these machines is specialized with unique Isolation Insertion Technology offering Blow Fill Seal (BFS). Our facility is available for non-regulated and medical devices.

Process Capability

  • Eye / Ear Drops
    • Batch Size :- 100 Lit – 600 Lit.
    • Fill volume :- 0.35ml, 5 ml,10 ml.
    • Dosage :- Aqueous Solution ∓ Steroids/Suspension.
    • Product Sterilization :- By Filtration
    • Resin Handled :- LDPE
  • Contact Lens Care Products
    • Batch Size :- 5000Lit. –10,000Lit.
    • Dosage :- Aqueous Solution
    • Fill volume :- 15ml.
    • Product Sterilization :- By Filtration
    • Resin Handled :- LDPE

Accreditations

  • WHO GMP 1993
  • SA MCC 2001, 2005
  • INVIMA (Columbia) 2004
  • ISO-9001: (Certified since 1996) 2000 ,2002
  • ISO-14001 2003 (Certified since 1999)
  • ISO 13485 2004
  • ISO 13485 2004
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Oral Solids Location

Aurora, Canada

This is our site for development and GMP manufacturing for complex pharmaceutical NCEs. It is located in Aurora, 50 kms north of Toronto.

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Lexington, USA

The Coldstream Laboratories manufacturing facility utilizes isolator technology for aseptic processing in a 22,000 square foot state‐of‐the art building.

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Riverview, USA

Our State-of the-Art FDA licensed cGMP facility in Riverview, USA, has over 50 years of extensive experience in delivering robust cGMP manufacturing processes..

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Grangemouth, UK

Grangemouth, UK is a USFDA and MHRA approved site dedicated to the contract development and manufacturing of Antibody Drug Conjugates since 2004.

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Morpeth, UK

The Pharma Solutions Morpeth site is one-of-a-kind US FDA and UK MHRA approved facility offering integrated services across the pharmaceutical value chain.

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Ahmedabad, India

Ahmedabad, India site was established in 2009. It is a MPA, Sweden approved and FDA approvable facility for development..

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Ahmedabad, India

Piramal Discovery Solutions site is located in Ahmedabad, India and provides a comprehensive range of early stage drug discovery services

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Mumbai, India

Operational since 2005, our Mumbai site is fully equipped for development of all liquid dosage forms both Sterile and Non-sterile.

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Pithampur, India

The Pithampur formulations site is a Greenfield project set in 1992 by Piramal Pharma Solutions. The US FDA and UK MHRA approved facility..

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Ennore, India

Ennore is identified as the India centre for development and early phase projects located near the Chennai port. The site is spread over an area of 75 acres..

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Digwal, India

It is a dedicated and multipurpose plant identified for custom manufacturing and development for late phase API’s and advanced intermediates.

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Mahad, India

It is a multipurpose plant identified for manufacturing of straight Vitamins & Vitamin Mineral Premixes.

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Aurora, Canada

This is our site for development and GMP manufacturing for complex pharmaceutical NCEs. It is located in Aurora, 50 kms north of Toronto.

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Lexington, USA

The Coldstream Laboratories manufacturing facility utilizes isolator technology for aseptic processing in a 22,000 square foot state‐of‐the art building.

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SHANGHAI, CHINA

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