Finished Dosage Manufacturing

We manufacture, supply and distribute commercial formulations for oral solids from our Sellersville, Morpeth and Pithampur facilities. Apart from OSDs we also provide liquids, creams and ointments from our Sellersville facility and sterile injectables from our Lexington site. 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.

Oral Solids

Our manufacturing facilities located in Sellersville- US, Morpeth- UK, and Pithampur- India, are USFDA inspected. These sites offer a broad spectrum of oral solids such as conventional tablets, modified release formulations, press coated tablets and hard gelatin capsules. We specialize in hormonal and potent oral solid formulations manufactured in a dedicated and segregated suite.

Dose Forms Handled

  • Tablets (Film-coated/IR/ER/MR)
  • Hard gelatin capsules (powders, granules, and pellets)
  • Special solid dosage forms
    • Press coated tablets (tablet in tablet)
    • Bi-layer tablets
    • Controlled release solids (Matrix)

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 with packaging capabilities
  • More than 40 years of handling hormonal products
  • Experienced in hormonal product development and the technical transfer
  • Experienced in handling a broad range of hormonal APIs

Sterile Injectables

Our sterile injectable manufacturing facility 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 ensures product containment for potent and cytotoxic compound products while providing an aseptic manufacturing environment.

Product Experience

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

Featured Services

  • Process Development & Optimization
  • cClinical 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

Salient Features

  • Class C (Class 10,000) formulation room
  • Class A (Class 100) biological safety cabinets in each formulation room

Liquids, Creams and Ointments

We offer development, manufacturing and packaging services for liquids, creams and ointments from our Sellersville, US facility. The manufacturing with the maximum capacity of 350 batches, 150 batches and 100 batches each.

Manufacturing Capabilities

  • Liquids:
    • 8 manufacturing suites
    • Potent suite – 2 rooms
    • Floor scales in 3 suites
    • Three 10,000L bulk holding tanks equipped with 2 propellers & steam jacket capable
  • Creams and ointments:
    • 9 manufacturing suites and 7 main manufacturing tanks
    • 2 tanks (SJ-20, SJ-41) equipped with counter rotating blades with side scrappers (both of 2000L capacity)
    • 3 high shear mixing tanks (SJ-7, SJ-18 and SJ-25) of 900L, 1000L and 2000L capacity
    • 4 rooms capable of utilizing portable tanks
    • 3 bulk holding tanks, each of 1000L
    • 1 Lydon dryer

Packaging Capabilities

  • Creams and ointments:
    • 15g-70g tube sizes
    • Norden tube filler - aluminium tubes/triple fold
    • Theoretical filler speed: 70 TPM
    • Norden carton machine
    • Poster bundler
  • Large volume liquids:
    • 120ml – 960ml bottle sizes (HDPE Bottles)
    • USB 15 Head Monoblock fill by weight filler
    • Theoretical filler speed: 70 BPM
    • Label-Aire labeler
    • Hamrick drop packer
  • Small volume liquid:
    • 100ml – 240 ml bottle sizes
    • Palace bottle unscramble
    • Capmatic – monoblock XP filler
    • Label Star labeller with Cognex vision system
    • IWKA carton machine
  • Rectal suspension:
    • McBrady orbit bottle rinser
    • Sig Pack DoBoy (pouch sealer)

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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