Z Luoyang Zhengmu Bio-Tech Veterinary API Manufacturer · China Request a Quote
Factory

Plant, Equipment & Quality Laboratory

Multi-purpose synthesis lines, a 300,000-grade clean plant for API finishing, and an analytical laboratory that releases every batch.
Zhengmu's factories are designed and planned by a professional pharmaceutical production design company to GMP requirements. The plant runs several production lines for the synthesis of APIs and intermediates, all built from glass or stainless steel and installed to GMP standards.

Production lines

The synthesis lines are multi-purpose by design. Reactors, condensers and receiving vessels are sized so that a sulfonamide campaign and a quinolone campaign can run on the same train without contaminating either product. Because the equipment train is shared, cleaning validation and campaign segregation are treated as part of the process, not as an afterthought.

The plant in pictures

Luoyang Zhengmu Bio-Tech API plant exterior in Yanshi, Henan
The production site at Liuzhuang Village, Goushi Town, Yanshi City, Henan Province.
Purified water generation system serving the API production lines
Purified water generation and distribution: filtration, softening and reverse osmosis skid.
Stainless steel twin-shell blender inside the clean plant
Stainless steel twin-shell blender used for homogenising API batches before packing.
Quality control analyst operating an HPLC in the on-site laboratory
Quality control laboratory: HPLC and UV-Vis used for assay and related substances.

Clean plant for API finishing

The refining, drying and packing workshop is a 300,000-grade clean plant. Material enters as wet cake or crude solid and leaves as packed, labelled API. Air is filtered and pressure-cascaded so that the packing area is never at lower cleanliness than the corridor beside it.
This is also where the physical attributes customers care about are set: particle size distribution, bulk density and flow. Adjusting crystallisation and drying conditions here is how we meet a customer's formulation requirement rather than simply meeting the pharmacopoeia.

Quality control laboratory

The QC laboratory is equipped with the instrumentation needed to release APIs against ChP, BP, EP and USP monographs without sending samples outside.
InstrumentWhat it is used for
High performance liquid chromatography (HPLC)Assay, related substances, residual solvents
Gas chromatography (GC)Volatile impurities and solvent residues
Infrared spectrophotometerIdentity confirmation against reference spectra
Ultraviolet spectrophotometerAbsorbance and content uniformity checks
Automatic titratorPotentiometric assay and acid-base determinations
Moisture analyserWater content by Karl Fischer and loss on drying
Automatic melting point analyserMelting range as an identity and purity check
pH analyserSolution pH for salts and soluble grades
Dust particle counterCleanroom classification and monitoring
Electronic analytical balanceWeighing for assay and reference standard preparation

Utilities and environmental control

Purified water, filtered air and temperature-controlled storage support the clean plant. Solvent handling, wastewater and exhaust are engineered as part of the site design, because a veterinary API plant that cannot manage its solvent load cannot keep a GMP certificate for long.

What a customer audit usually covers

Audits can be arranged through the contact page. We prefer to schedule them before the first commercial order, so that any gap is closed while it is still a documentation exercise rather than a shipment delay.

Planning a supplier qualification?

Ask for the plant layout summary, equipment list and a sample batch record package.
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Factory views


Our plants and facilities are designed and planned by a professional pharmaceutical production design company with GMP requirements: we own a number of production lines for the synthesis of APIs and intermediates; all production equipments are glass or stainless steel, and their selection and installation are in line with GMP requirements, can meet the production requirements of a variety of APIs. The refined bakery plant of APIs is a 300,000-level clean plant, and can satisfy the production requirements of various types of APIs.