GMP · FDA · ISO 9001:2015 Certified

Manufacturing Excellence
for Global Pharma

Precision Pharma delivers contract manufacturing of APIs and finished dosage forms with uncompromising quality standards — trusted by 120+ pharma companies worldwide.

Request a Quote → Our Capabilities
120+
Global Clients
25+
Years Experience
98%
On-Time Delivery

25 Years of Pharmaceutical Manufacturing Precision

Founded in 1999, Precision Pharma Manufacturing Ltd has grown from a regional API producer into one of the world's most trusted contract pharmaceutical manufacturers. Our 180,000 sq ft state-of-the-art facility houses end-to-end capabilities from early-phase development to commercial-scale production.

We partner with biotech startups, generic manufacturers, and Big Pharma alike — delivering regulatory-compliant product with the speed and flexibility that modern pharmaceutical development demands.

180k sqft
Manufacturing Floor
850+
Qualified Scientists
450+
Products Registered
60 Countries
Export Markets
Learn Our Story
Since 1999
25 Years of Excellence
Zero critical FDA observations
Current cGMP Status
Fully Compliant

End-to-End Manufacturing Capabilities

From API synthesis to finished dosage form, sterile manufacturing to packaging — one partner for your entire product lifecycle.

API Manufacturing

Multi-step synthesis, fermentation, and semi-synthesis of active pharmaceutical ingredients at commercial scale.

Oral Solids Injectables Biologics

Sterile Manufacturing

ISO Class 5-8 cleanrooms for aseptic processing of injectables, lyophilized products, and ophthalmic preparations.

Class A/B Lyophilization Fill/Finish

Analytical R&D

Full analytical method development, validation, and stability studies supporting IND/NDA/ANDA regulatory submissions.

Method Dev. ICH Stability Impurity Profiling

Oral Solid Dosage Forms

High-speed tablet compression, film coating, hard/soft capsule filling, and granulation with full PAT integration.

Tablets Capsules Modified Release

Drug Product Development

Formulation development from pre-IND through Phase III, with integrated CMC regulatory support and tech transfer.

Formulation CMC Support Tech Transfer

Quality & Compliance

Comprehensive QMS, batch record review, regulatory agency inspection readiness, and post-approval change management.

QbD 21 CFR Part 211 EU GMP

From Concept to Commercial Scale

A structured, stage-gate development pathway that de-risks your program at every phase.

01

Discovery & Feasibility

Pre-formulation studies, solubility screening, polymorph assessment

02

Formulation Development

DoE-driven formulation optimization, prototype manufacturing, in vitro testing

03

Scale-Up & Pilot

Process optimization, pilot batch manufacture, analytical method validation

04

Clinical Manufacturing

Phase I-III cGMP batches, IND/CTA filing support, stability programs

05

Validation

Process validation, cleaning validation, equipment qualification per ICH Q7/Q8

06

Commercial Launch

Commercial-scale production, supply chain integration, post-approval support

Our Product Portfolio

View All Products
API

Cardiovascular APIs

ACE inhibitors, ARBs, statins, and anti-arrhythmic compounds

Multi-kilogram to multi-tonne capabilities with full ICH Q7 compliance. DMF filing support included.

cGMP Certified DMF Available
Finished Dosage

Oncology Formulations

Cytotoxic oral and injectable products in dedicated containment suites

Potent compound handling to OEB-5 standards. Isolator technology and ISPE-compliant containment.

OEB-5 Capable HPAPI
Sterile

Sterile Injectables

Aseptic fill/finish for vials, prefilled syringes, and lyophilized products

RABS and isolator technology. Capacity: 15 million vials/year. Full regulatory batch records.

ISO Class 5 Lyophilization

Partners & Clients Worldwide

From emerging biotechs to top-20 global pharma companies

NovaBio
GENIX LABS
Medivance
PHARMATEC
Celestrix
APEX PHARM
BioForge
QUANTUM RX
Heliogen
OMNILAB

Technical & Regulatory Resources

Download our capability overview, quality manual, and regulatory compliance documentation.

Capability Overview PDF Quality Manual Regulatory Summary
Ready to Start?

Partner With a Manufacturer You Can Trust

Whether you need Phase I clinical batches or 100 million units of commercial supply — we're equipped and ready.