COSMETICS & PERSONAL CARE
Nexchem
Jinhua, Zhejiang, China · Established December 2002 · Joint venture API manufacturer
Macrolide depth, with the compendial paperwork to match.
Macrolide antibiotics are difficult APIs to make well. The semi-synthetic route from the erythromycin backbone is long, the polymorphism is troublesome, and the impurity profile is unforgiving. Nexchem has built a single-site operation around exactly that chemistry, and has the filings to prove the output is reproducible.
Established in 2002 as a joint venture in Jinhua, Zhejiang, the company operates a 63-acre site with more than 860 employees. Its azithromycin, clarithromycin, roxithromycin, benserazide hydrochloride and fenofibrate lines hold GMP certification, and Certificates of Suitability are held for clarithromycin, fenofibrate and glimepiride.
- Cosmetics & Personal Care
Over 400 mineral salts and more than 7,000 specifications. The specification count is the more meaningful number: it is the measure of how far a grade can be tailored.
ABOUT THIS PRINCIPAL
A focused API base rather than a broad catalogue.
Nexchem was established in December 2002 as a joint venture specialising in the research, production and sale of active pharmaceutical ingredients. The site sits in the Linjiang Industrial Zone at Jinhua in Zhejiang province and covers roughly 63 acres. Over 860 people work there, including doctoral and masters-level technical staff, with management experience and technical support drawn from the Jinhua Kangenbei organisation.
The strategy has been depth rather than breadth: build a characteristic API production base around a small number of molecules and file properly on each. GMP certificates are held for azithromycin, clarithromycin, roxithromycin, benserazide hydrochloride and fenofibrate. Certificates of Suitability are held for clarithromycin, fenofibrate and glimepiride, and clarithromycin has additionally been certified by the Japanese PMDA.
For a formulator, the practical consequence is that the filings are current and the manufacturing history sits at one site. Multi-site sourcing arrangements are where most API qualification problems begin.
Depth on a small number of molecules, filed into multiple jurisdictions, is a more useful supplier profile than breadth with thin regulatory coverage.
ADCHEM distributes the Nexchem API range with regulatory and qualification support, including impurity profile review, filing reference coordination, and assistance assembling the documentation your submission requires.
FEATURED TECHNOLOGY
Four things that decide macrolide API quality.
Anyone can quote a macrolide. The differences that matter appear during qualification.
ROUTE
Semi-synthetic chemistry from the erythromycin backbone
Ingredient development grounded in dermal science with analytical capability attached, so mechanism and measurement are developed together rather than sequentially.
SOLID STATE
Polymorph and hydrate control
Macrolides exist in multiple crystal forms and hydration states with materially different dissolution behaviour. Reproducible solid-state control is the difference between a bioequivalent product and a failed batch.
PARTICLE
Particle size and flow engineering
Macrolide APIs are notoriously difficult to handle in high-dose solid formats. Particle size distribution and bulk properties are specified rather than left to the crystallisation to decide.
FILINGS
Multi-jurisdiction regulatory coverage
Certificates of Suitability, Japanese DMF registration and GMP certification across the principal lines mean the supporting documentation exists before you ask for it.
Portfolio
The Nexchem API portfolio.
A focused range, filed in depth rather than listed in breadth.
Azithromycin
What it is
Second-generation macrolide antibiotic; GMP certified line
Primary Use
Respiratory, skin and soft tissue, and genitourinary anti-infectives
Azithromycin dihydrate
What it is
Hydrated crystalline form of azithromycin
Primary Use
Oral solid and suspension formats where the dihydrate is the specified form
Clarithromycin
What it is
Macrolide antibiotic; CEP/COS held and certified by the Japanese PMDA
Primary Use
Respiratory anti-infectives and Helicobacter pylori eradication regimens
Roxithromycin
What it is
Semi-synthetic macrolide antibiotic; GMP certified line
Primary Use
Respiratory tract and soft tissue infection therapy
Fenofibrate
What it is
Fibrate lipid-regulating agent; GMP certified line with CEP/COS held
Primary Use
Hypertriglyceridaemia and mixed dyslipidaemia
Glimepiride
What it is
Third-generation sulfonylurea; CEP/COS held
Primary Use
Type 2 diabetes therapy, alone or in fixed-dose combination
Benserazide hydrochloride
What it is
Peripheral decarboxylase inhibitor; GMP certified line
Primary Use
Parkinson's disease therapy in combination with levodopa
Acitretin
What it is
Second-generation systemic retinoid
Primary Use
Severe psoriasis and disorders of keratinisation
Alizapride and alizapride hydrochloride
What it is
Substituted benzamide antiemetic
Primary Use
Nausea and vomiting, including chemotherapy-associated presentations
Macrolide intermediates
What it is
Erythromycin-derived intermediates including the azithromycin precursor
Primary Use
Captive use and supply to downstream macrolide manufacturers
Carbapenem intermediates
What it is
Advanced intermediates for the carbapenem class
Primary Use
Supply into sterile antibiotic manufacture
APPLICATION AREAS
Where Nexchem APIs are used.
Respiratory anti-infectives
The macrolide range covers the principal molecules used in community-acquired respiratory infection across tablet, suspension and sachet formats.
AZITHROMYCIN
CLARITHROMYCIN
ROXITHROMYCIN
Eradication regimens
Clarithromycin with PMDA certification and a Certificate of Suitability, for combination therapy where documentation quality is scrutinised.
CLARITHROMYCIN
Lipid management
Fenofibrate with CEP coverage, for hypertriglyceridaemia and mixed dyslipidaemia formulations.
FENOFIBRATE
Diabetes
Glimepiride with a Certificate of Suitability, for monotherapy and fixed-dose combination products.
GLIMEPIRIDE
Neurology
Benserazide hydrochloride for levodopa combination therapy in Parkinson's disease.
BENSERAZIDE HCL
Dermatology and supportive care
Acitretin for severe keratinisation disorders, and alizapride for antiemetic applications.
ACITRETIN
DOCUMENTATION TO BE HELD
Regulatory documentation that supports the filing, not just the purchase order.
Nexchem supplies the documentation set required for API qualification and regulatory submission, including compendial compliance evidence, impurity profiles, and reference to Certificates of Suitability and Japanese DMF registrations where held. Single-site manufacture simplifies the change-control and traceability picture that qualification audits examine most closely.
Product & quality
- Product specification sheet
- Certificate of Analysis (CoA), batch specific
- Safety Data Sheet (SDS / MSDS)
- Compendial compliance statement against USP/NF, Ph. Eur., JP or BP as applicable
- Analytical methods and method validation summary
- Physical characterisation data: particle size distribution, bulk and tapped density, loss on drying
- Stability data with retest period or shelf life justification
Composition and safety
- Drug Master File number with Letter of Access
- Certificate of Suitability (CEP / COS) where filed
- Written Confirmation for API import into the European Union
- Manufacturing licence and site registration details
- Open part documentation for inclusion in the applicant’s submission
- Regulatory support commitment for market registration and variations
GMP and quality system
- GMP certificate for the manufacturing site
- Excipient GMP statement aligned to IPEC-PQG or EXCiPACT, for excipient grades
- ISO 9001 certificate
- Quality Agreement
- Change control and prior notification commitment
- Most recent regulatory inspection outcome summary
- Completed supplier questionnaire or audit report
Impurities and biological safety
- Elemental impurities risk assessment (ICH Q3D)
- Residual solvents data (ICH Q3C)
- Genotoxic and mutagenic impurity assessment (ICH M7)
- Nitrosamine risk evaluation
- Related substances and impurity profile with named and characterised impurities
- Microbiological limits and bioburden data
- Bacterial endotoxin data where the grade or route requires it
Origin and declarations
- Manufacturing process flow chart and route of synthesis summary
- Starting material identity and origin statement
- TSE / BSE-free declaration
- GMO-free statement
- Allergen statement
- Residual antibiotic and cross-contamination control statement
- Latex-free and melamine-free statements
- Country of origin declaration
- Halal and Kosher certificates where required by the market
- Packaging and container closure specification
WORKING WITH ADCHEM
What ADCHEM adds to the Nexchem relationship.
PRE-QUALIFICATION
Impurity profile review before you commit
Macrolide qualification most often fails on the impurity profile. We obtain and review it against your specification before samples are ordered.
SUBMISSION-READY
Filing reference coordination
CEP and DMF reference letters, open and closed part arrangements, and change notifications coordinated between manufacturer and your regulatory affairs team.
SPECIFICATION-LED
Solid-state and particle specification
Polymorph, hydrate and particle size requirements agreed and written into the specification at qualification, not discovered during scale-up.
AUTO-ATTACHED VIA COSMO
Full documentation with every sample
Specification, SDS, CoA, compendial statement, impurity profile and applicable filing references dispatched with the sample as standard, via COSMO.
On this page
Quick facts
GROUP HEADQUARTERS
Malmo, Sweden
PERSONAL CARE SINCE
1989
PARENT
AAK AB, listed on Nasdaq Stockholm, 150 years of history
SEGMENT
Plant-based emollients, butters and actives for beauty and personal care
SCALE
Approximately 3,900 employees; 25 regional sales offices; 15 Customer Innovation Centers; more than 20 production facilities
PRIMARY FEEDSTOCKS
Shea, canola and coconut
CERTIFICATIONS
COSMOS, Ecocert, RSPO, Rainforest Alliance, Vegan Society, Halal, Kosher, NATRUE, China-compliant grades
A focused API base with the filings already in place.
Three ways to start: a sample, a specification and impurity profile, or a conversation with a specialist who will ask about your submission route first.
Request a Sample
Any product in the portfolio
Request Technical Data
Full technical library
Talk to Our Specialist
Someone who knows the chemistry first
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