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Shenzhen Oriental PharmaceuticalShenzhen Oriental PharmaceuticalOrientalSpecialty APIs since 1995
GMP & US-FDA inspected API manufacturer

Specialty active pharmaceutical ingredients for the world's regulated markets

Since 1995 we have supplied phenylephrine, norepinephrine, doxylamine and other sympathomimetic and CNS APIs to pharmaceutical manufacturers across Europe, North America and beyond — backed by repeatedly US FDA-inspected GMP sites and US-DMF, EDMF/ASMF and Written Confirmation documentation.

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30+Years in API manufacturing
31APIs & advanced intermediates
40+Export markets worldwide
US FDA inspected · US-DMF · EDMF/WC 
FDA-inspected & cGMP-compliant API manufacturerFDA-inspected & cGMP-compliant API manufacturer
Shenzhen Oriental PharmaceuticalFlagship products
Phenylephrine HydrochlorideCAS 61-76-7 · USP/EP/CP
EU WC GD250011 · US-DMF on request
Phenylephrine BitartrateCAS 17162-39-9 · USP
Available on request
Doxylamine succinateCAS 562-10-7 · USP
EU WC GD250028 · FDA CPP H9AE-5J4P (Mexico)
Etilefrine HCLCAS 943-17-9 · EP
EDMF
Inside our facilities

Real GMP production and quality control

Every photograph below was taken at our Shenzhen manufacturing site — final-form packaging in the cleanroom, the QC laboratory and the synthesis floor.

Shenzhen HQ and manufacturing campus
Shenzhen HQ and manufacturing campus
Final-form handling in the cleanroom
Final-form handling in the cleanroom
QC laboratory — HPLC determination
QC laboratory — HPLC determination
Synthesis floor — glass-lined reactors
Synthesis floor — glass-lined reactors
Cleanroom process vessel, GMP gowning
Cleanroom process vessel, GMP gowning
QC laboratory — GC / headspace analysis
QC laboratory — GC / headspace analysis
Flagship products

The molecules we are known for

High-demand sympathomimetic, antihistamine and CNS APIs, manufactured in dedicated GMP workshops with ample stock and fast turnaround.

Phenylephrine Hydrochloride

Flagship
Cardiovascular & Vasopressors
CAS61-76-7
StandardUSP/EP/CP
Regulatory filesEU WC GD250011 · US-DMF on request
· SDS & CoA available on request

Phenylephrine Bitartrate

Flagship
Cardiovascular & Vasopressors
CAS17162-39-9
StandardUSP
Regulatory filesAvailable on request
· SDS & CoA available on request

Doxylamine succinate

Flagship
Antihistamines
CAS562-10-7
StandardUSP
Regulatory filesEU WC GD250028 · FDA CPP H9AE-5J4P (Mexico)
· SDS & CoA available on request

Etilefrine HCL

Flagship
Cardiovascular & Vasopressors
CAS943-17-9
StandardEP
Regulatory filesEDMF / WC
· SDS & CoA available on request

Epinephrine (Adrenaline)

Flagship
Cardiovascular & Vasopressors
CAS51-43-4
StandardUSP
Regulatory filesNMPA 2024YS00075 · EU WC GD250019
· SDS & CoA available on request

Selegiline HCL

Flagship
CNS & Neurology
CAS14611-52-0
StandardUSP
Regulatory filesAvailable on request
· SDS & CoA available on request
Why Oriental

Few niches. In each, a chain we control end to end.

Regulatory-ready documentation

US-DMF, EDMF/ASMF and Written Confirmation for key products, and manufacturing sites that have repeatedly passed US FDA inspections — ready to support your filing in the US, EU, Canada and other regulated markets.

Customization on demand

Particle size, bulk density and salt form tailored to your formulation, produced to the latest USP, EP and CP specifications.

Agile, stocked delivery

Dedicated workshops and safety stock let us respond to urgent and tender orders without the lead times of a large CMO.

Audit-transparent quality

A GMP quality system spanning R&D, production and QC. We welcome customer and authority on-site audits.

Compliance you can file with

Compliance you can file with

Our quality and regulatory standing, at a glance.

GMP certified

Multiple GMP certifications across our Shenzhen sites.

US FDA inspected

Repeatedly passed US FDA inspections; phenylephrine among the inspected products.

Drug Master Files

US-DMF and EDMF/ASMF dossiers available for registration in major markets.

EU filings: EDMF/ASMF + Written Confirmation

EU market entry is supported today through EDMF/ASMF dossiers and Written Confirmation; CEP applications for selected products are under review at EDQM.

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