APOMORPHINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mdd Us	APOKYN	apomorphine hydrochloride	INJECTABLE;SUBCUTANEOUS	021264	NDA	MDD US Operations, LLC	27505-004-05	5 CARTRIDGE in 1 CARTON (27505-004-05) / 3 mL in 1 CARTRIDGE (27505-004-01)	2004-07-02
Tp Anda Holdings	APOMORPHINE HYDROCHLORIDE	apomorphine hydrochloride	INJECTABLE;SUBCUTANEOUS	212025	ANDA	TruPharma, LLC	52817-720-05	5 CARTRIDGE in 1 CARTON (52817-720-05) / 3 mL in 1 CARTRIDGE (52817-720-01)	2022-02-24
Mdd Us	ONAPGO	apomorphine hydrochloride	SOLUTION;SUBCUTANEOUS	214056	NDA	MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc	27505-006-05	5 CARTRIDGE in 1 CARTON (27505-006-05) / 20 mL in 1 CARTRIDGE (27505-006-01)	2025-02-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Apomorphine Hydrochloride is a potent dopamine agonist primarily used in the management of Parkinson’s disease and acute intervention in opioid overdose. Its pharmacological efficacy depends on high-quality manufacturing, demanding strict compliance with Good Manufacturing Practices (GMP) and regulatory standards. Consequently, identifying reputable suppliers capable of providing pharmaceutical-grade Apomorphine Hydrochloride is crucial for pharmaceutical companies, compounding pharmacies, and research institutions. This article offers a comprehensive overview of current suppliers, their capabilities, certification status, and market landscape.

Overview of Apomorphine Hydrochloride

Apomorphine Hydrochloride (C17H17NO2·HCl) is an alkaloid derivative with dopaminergic activity. It is typically supplied as a powder or a sterile solution. Due to its potency and the sensitivity of its manufacturing process, sourcing from reliable suppliers with proven quality control is imperative. The global pharmaceutical supply chain for Apomorphine Hydrochloride is concentrated among several key players—including chemical manufacturers, API producers, and specialized compounding suppliers.

Major Suppliers of Apomorphine Hydrochloride

1. European and North American Suppliers

a. Novartis AG

Overview: Novartis, a Swiss multinational pharmaceutical company, historically supplied Apomorphine Hydrochloride for medical use, notably via its subsidiary products.
Capabilities: Established manufacturing facilities for dopaminergic agents, including Apomorphine formulations.
Certification: GMP-compliant, with extensive regulatory approvals in Europe and North America.
Notes: Novartis's supply may be restricted to licensed pharmaceutical formulations, and direct procurement might be limited to authorized distributors.

b. Bramcote Chemicals Ltd. (UK)

Overview: Specialized in research chemicals and APIs, Bramcote offers pharmaceutical-grade Apomorphine Hydrochloride for research and clinical trials.
Capabilities: Provides both powder and injectable formulations suitable for clinical applications, with batch-specific certificates.
Certification: CE and GMP accreditation, ensuring regulatory compliance within Europe.

c. Toronto Research Chemicals (TRC), Canada

Overview: Known for supplying research-grade Apomorphine Hydrochloride for laboratory use.
Capabilities: Offers high-purity API suitable for preclinical studies; not intended for human administration without further manufacturing.
Certification: Certificates of Analysis (CoA), but typically not GMP-certified for pharmaceutical production.

2. Asian Suppliers and API Manufacturers

a. Zhejiang Hisun Pharmaceutical Co., Ltd., China

Overview: A major Chinese API manufacturer with broad pharmaceutical manufacturing capabilities.
Capabilities: Produces Apomorphine Hydrochloride for export into global markets, compliant with international GMP standards.
Certification: GMP-certified; exports to Europe and North America, subject to regulatory approvals.

b. Zhejiang Hisun Pharmaceuticals Co., Ltd.

Overview: Offers chemically synthesized APIs for various indications.
Capabilities: Aimed at pharmaceutical companies seeking raw materials for drug development and commercial manufacturing.
Notes: Active in expanding their API portfolio, including neuropharmacological agents.

c. Alembic Pharmaceuticals Ltd., India

Overview: A notable Indian API producer with worldwide distribution networks.
Capabilities: Manufactures and supplies Apomorphine Hydrochloride API under strict GMP conditions.
Certification: WHO-GMP and local regulatory approvals—favorable for international markets.

3. Specialty and Compounders

a. Hofmann La Roche (Switzerland)

While Roche has historically supplied Apomorphine for Parkinson’s therapy, direct procurement avenues may be limited to licensed partners.
They focus more on formulation than raw API manufacturing but remain critical in the supply chain for finished drug products.

b. Sandoz (Novartis division)

Restricted to the formulation and distribution of finished products, Sandoz’s role might be applicable for compounded supplies in specific markets.

Important Considerations in Supplier Selection

Regulatory Compliance: Only acquire Apomorphine Hydrochloride from GMP-certified suppliers to ensure compliance with regulatory standards for pharmacological or research use.
Purity and Quality Control: Verify Certificates of Analysis and batch-specific testing results for impurity profiles, potency, and stability.
Intended Use: Differentiate between suppliers providing API suitable for clinical trial, research, or commercial manufacturing.
Supply Chain Security: Evaluate suppliers for reliable delivery, documentation, and geopolitical stability of manufacturing regions.

Emerging Trends in Supplier Markets

Regulatory Harmonization: Increased convergence of GMP standards across Asia facilitates easier procurement from Chinese and Indian manufacturers.
Contract Manufacturing Organizations (CMOs): Growth in CMOs offering tailored manufacturing and custom synthesis of Apomorphine Hydrochloride for biotech and pharma clients.
Quality Certifications Expansion: Suppliers increasingly acquire ISO certifications and specialized quality assurance measures to meet global demand.

Conclusion

The global landscape of Apomorphine Hydrochloride suppliers is characterized by a mix of established pharmaceutical giants, regional API manufacturers, and research chemical providers. High-quality procurement hinges on rigorous verification of GMP certification, documentation, and supply chain integrity. With increasing regulatory rigor and demand for pure, well-characterized APIs, pharmaceutical and research entities must perform due diligence and establish robust vendor qualification processes. Sourcing from reputable, certified suppliers mitigates risks related to quality, regulatory compliance, and supply continuity.

Key Takeaways

Select GMP-certified suppliers—ensuring high purity, consistent quality, and regulatory compliance for pharmaceutical applications.
Verify Certificates of Analysis and batch records—important for research, clinical, or commercial manufacturing.
Diversify supply sources—to mitigate risks associated with geopolitical, logistical, or regulatory disruptions.
Prioritize suppliers with global regulatory approvals—especially for import-dependent markets.
Stay abreast of emerging suppliers—especially those in Asia adapting to global GMP standards and expanding capacity.

FAQs

1. Is Apomorphine Hydrochloride readily available from all major pharmaceutical suppliers?
Availability varies; established pharmaceutical companies with GMP-certified manufacturing often supply for clinical or commercial use, but generic APIs may be more accessible from regional suppliers or research chemical vendors.

2. Can research-grade Apomorphine Hydrochloride be used directly in human therapeutics?
No. Research-grade APIs are not manufactured or tested to pharmaceutical standards required for human use. Clinical-grade or licensed formulations are necessary for patient administration.

3. What regulatory considerations should be taken when sourcing Apomorphine Hydrochloride internationally?
Ensure the supplier complies with GMP standards; verify export and import licenses; confirm that Certificates of Analysis meet local regulatory requirements.

4. Are there alternative suppliers in markets with less stringent regulatory oversight?
While options exist, reliance on non-GMP suppliers can impact product quality and regulatory approval. It is advisable to maintain compliance by choosing certified sources.

5. What steps should companies take to qualify a new supplier for Apomorphine Hydrochloride?
Conduct a supplier audit, review manufacturing and quality control practices, verify certifications, and perform initial testing of batches before establishing long-term procurement agreements.

References

European Medicines Agency. Guidelines on Good Manufacturing Practice for Medicinal Products. EMA, 2022.
US Food and Drug Administration. Current Good Manufacturing Practice (CGMP) Regulations, 21 CFR Parts 210 and 211.
Zhejiang Hisun Pharmaceutical Co., Ltd. Official Website, 2023.
Toronto Research Chemicals. Chemical Product Data Sheet. TRC, 2023.
Novartis Official Website. Company Profile and Global Supply Chain. Novartis AG, 2022.

Suppliers and packagers for generic pharmaceutical drug: APOMORPHINE HYDROCHLORIDE