6-8
Oct
2026
Nanjing Milestone Pharma Co., Ltd
About Nanjing Milestone Pharma Co., Ltd
Certifications
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FDA -
GMP
Categories
Meet us at
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CPHI Milan 2026
Fiera Milano, Italy
6 Oct 2026 - 8 Oct 2026
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Country/Region:China
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Founded:2016
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On CPHI since:2023
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Certificates:3
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Employees:250 - 499
Company types
Primary activities
Products from Nanjing Milestone Pharma Co., Ltd (7)
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Product Analytical Method Development & Validation
Our phase-appropriate solutions cover method design, qualification, validation, and transfer, ensuring robust performance from preclinical to commercialization. Leveraging advanced chromatographic, spectroscopic, and physicochemical techniques, we support small molecules, biologics, and complex formulation... -
Product In-Vitro-Bioequivalence
Integrated in vitro bioequivalence support across oral, topical, transdermal, nasal, inhalation, injectable, and nanomedicine products.
Capabilities include dissolution and release testing, IDR, IVRT, IVPT, permeability studies, spray and particle characterization, binding assays, cyclodextrin i... -
Product Large Molecule Characterization
We deliver comprehensive large-molecule characterization for peptides, oligonucleotides, proteins, antibodies, vaccines, and biologic/chemical conjugates. Our integrated analytical packages support CMC development, comparability assessments, and submission-ready documentation—helping you make confident, da... -
Product Nano Particle _banner_pc_2x.webp Particle Characterization for Biologics & ATMPs
Milestone Pharma provides particle characterization for biologics and advanced therapy medicinal products (ATMPs), delivering fit-for-purpose data to support formulation development, stability and comparability, and CMC submissions.
We design orthogonal analytical strategies across size, morphol... -
Product Nitrosamine & NDSRI Services
Milestone Pharma's Nitrosamine and NDSRI Research Platform delivers a comprehensive and compliant one-stop solution, covering risk assessment, method development and validation, confirmatory testing, and submission-ready report generation.
The platform strictly adheres to ICH, FDA, and EMA guide... -
Product Pharmaceutical & Medical Device Testing (E&L, Sterility, Biocompatibility)
Our capabilities cover pharmaceutical packaging testing, extractables and leachables (E&L) studies, container closure integrity testing (CCIT), sterility assurance, biocompatibility testing, chemical characterization, and global regulatory support. Backed by ISO 17025-accredited laboratories and experi... -
Product Reference Standards & Impurity Synthesis
Nitrosamine impurity is a key component of Milestone Pharma‘s custom impurity services. The nitrosamine-related compounds and reference standards listed on this page support drug development and quality control applications. Our strengths include an integrated multi-platform strategy, deep methodological e...