Changzhou Ruiming Pharmaceutical Co., Ltd. is a Chinese pharmaceutical manufacturer founded in 2005 and based at No.1558 Longjiang North Road, Chunjiang Town, Xinbei District, Changzhou City, Jiangsu Province. The company carries out research, development, production and sales of pharmaceutical intermediates, active pharmaceutical ingredients (APIs) and preparations related to cardiovascular, urinary, respiratory and digestive systems. It operates a 25,000 m² site with two API production lines and one solid preparation production line.

 

This analysis examines the company as a candidate API supplier for regulated markets. It covers corporate profile, product portfolio and specifications, manufacturing and quality infrastructure, published certification status, and the practical procurement points a formulation company or distributor should confirm before qualification.

Why API Supplier Qualification Is the Real Sourcing Problem

Selecting an API source for a regulated market is a documentation and traceability exercise before it becomes a commercial negotiation. A finished-dose manufacturer does not simply buy a chemical; it adopts a supplier into its own regulatory dossier, and every claim made about that supplier must be defensible in front of an assessor.

The consequences of choosing poorly are structural rather than transactional. A supplier without the right pharmacopoeial compliance, without a GMP inspection history that reviewers recognise, or without a complete technical package can delay a filing by months, force a reformulation, or make an approved product difficult to defend at renewal. Price differentials between sources are usually modest compared with the cost of re-qualifying a supplier mid-project.

The practical question for a buyer is therefore narrow and specific: can this manufacturer support my dossier, my market, and my batch scale, and can it prove that with documents I can submit? Everything else — catalogue breadth, brand familiarity, sales responsiveness — is secondary.

Industry Background: What Regulated-Market API Buyers Screen For

In the global API supply chain, suppliers are separated less by chemistry than by evidence. Three evidence layers typically decide whether a manufacturer is viable for a regulated market.

• Pharmacopoeial conformity. The API must be shown to comply with a recognised monograph — United States Pharmacopeia (USP), European Pharmacopoeia (EP) or British Pharmacopoeia (BP). Buyers check whether the stated standard matches the market they are filing in.
• GMP status and inspection history. API manufacture is governed by GMP expectations aligned with ICH Q7. A domestic GMP inspection is a baseline; a European Directorate for the Quality of Medicines & HealthCare (EDQM) inspection, a US Food and Drug Administration (FDA) on-site inspection, or a Japan Pharmaceuticals and Medical Devices Agency (PMDA) certification indicates exposure to regulators beyond the home market.
• Documentation availability. Certificates of Analysis, Safety Data Sheets, open and closed part documentation, and registration support files determine how quickly a customer can actually use the material in a submission.

Suppliers that have only domestic registration are not unsuitable — they are simply at an earlier stage of the same journey. The analytical task is to place a manufacturer accurately on that journey rather than accept a marketing claim at face value.

Company Profile: Scale, Site and Structure

Ruiming was founded in 2005 and is adjacent to the Shanghai–Nanjing Expressway, which the company cites as a transport advantage. It manufactures APIs as specified in its Drug Production License. The licensed production scope covers Propafenone Hydrochloride, Tamsulosin Hydrochloride, Felodipine, Amlodipine Besilate and Levoamlodipine Besylate.

The physical footprint includes synthesis workshops; final purification, drying and packaging workshops built to GMP requirements; liquid raw material warehouses; solid raw material warehouses; an intermediate warehouse; and finished product warehouses. On the audited Amlodipine Besilate line, the relevant areas are the synthesis workshop together with the final purification, drying and packaging workshop, which the company states are mainly dedicated to formulation projects.

 

Core Products and Specifications

The published portfolio centres on cardiovascular and urological APIs. The main products are Amlodipine Besylate, Levoamlodipine Besylate, Propafenone Hydrochloride and Tamsulosin HCl, with Felodipine listed in the licensed production scope and product catalogue.

Amlodipine Besylate — CAS 111470-99-6

Amlodipine Besylate is a dihydropyridine calcium channel blocker supplied as an active pharmaceutical ingredient with no excipients. Published specifications state an assay of 98.0%–102.0%, compliance with USP and EP standards, a melting point of 197°C–201°C, packing at 25 kg per drum, and a minimum order quantity of 1 kg. It is used as an anti-hypertension API and is suitable for tablet formulation. Impurities are described as strictly controlled.

Levoamlodipine Besylate — CAS 103129-82-4

Levoamlodipine Besylate is a calcium channel blocker API in the dihydropyridine derivative category, with molecular formula C₂₀H₂₅ClN₂O₅·C₆H₆O₃. The specification states an assay of 98.0%–102.0% on dried basis, compliance with USP and EP, GMP compliance, and storage protected from light, sealed, in a cool and dry place. Single impurity and total impurity levels are described as under tight control. It is supplied as a pharmaceutical pure powder for antihypertensive tablet formulation; it is an API, not a finished dosage form.

Felodipine — CAS 72509-76-3

Felodipine is a calcium channel blocker active pharmaceutical ingredient and a dihydropyridine derivative with molecular formula C18H19Cl2NO4. The specification states an assay of 98.0%–101.0% on dried basis, compliance with USP, EP and BP monographs, and GMP compliance. Typical application scenarios are finished drug formulation for hypertension and stable angina pectoris. Storage conditions are protected from light, sealed, cool and dry.

Propafenone Hydrochloride — CAS 34183-22-7

Propafenone Hydrochloride is an active pharmaceutical ingredient in the cardiovascular API category, with EINECS number 251-867-9, molecular formula C21H28ClNO3, molecular weight 377.9049, boiling point 519.6°C, flash point 268°C and vapour pressure 1.27E-11 mmHg at 25°C. It is NMPA registered and Chinese GMP compliant, with a Certificate of Pharmaceutical Product (COPP) available. The site has passed EU and PMDA audits with an ICH Q7 aligned system, and the product complies with EP, USP and CP monographs. Impurities are described as well controlled, and particle size can be customised, including micronisation service. It is manufactured in an in-house integrated GMP workshop with flexible batch sizes from laboratory to commercial scale, and a full CTD documentation package is available with technical support for registration and audit.

Tamsulosin Hydrochloride — CAS 106463-17-6 / 80223-99-0

Tamsulosin Hydrochloride, also referred to as Tamsulosin HCL, is listed as an active pharmaceutical ingredient with two CAS numbers: 106463-17-6 and 80223-99-0. Its molecular formula is C₂₀H₂₉ClN₂O₅S, molecular weight 444.9727, melting point 228–230°C, boiling point 595.5°C at 760 mmHg, flash point 313.9°C and vapour pressure 3.79E-14 mmHg at 25°C. The product page records an FDA on-site inspection in 2018, a registration on-site verification and GMP compliance inspection in 2022, and a GMP compliance inspection in 2024. Batch specifications, impurity controls, packaging and supply conditions are confirmed through the relevant quality documents and purchasing requirements.

Other Listed Specifications

The published material also lists Upadacitinib API at a purity specification of at least 99% by HPLC, supplied as a white or off-white crystalline powder. Buyers evaluating molecules outside the cardiovascular and urological core should confirm current availability, registration status and documentation scope directly, since published specification data and registration status are not the same thing.

Manufacturing, Quality and Supply Capability

Manufacturing capability at Ruiming is concentrated in the cardiovascular and urological API range rather than spread across a broad catalogue. Two API production lines support an annual output of 180 tons, with 25 kg per drum as the standard packing format for Amlodipine Besylate and the option of flexible packing.

The main production equipment is documented at unit-operation level rather than as a general claim: amlodipine base hydrolysis reactors, amlodipine besilate salt-forming reactors, centrifuges, decolorisation reactors, crystallisation reactors, double cone rotary vacuum dryers, high-efficiency pulverisers and double cone blenders. Unit-operation equipment maps directly to the process steps a customer needs to understand during technical due diligence — salt formation, isolation, crystallisation, drying and particle-size reduction.

 

On quality, the company states that its process equipment and quality testing instruments meet current domestic pharmaceutical production and quality management requirements and are capable of supporting production and quality control for existing products. The site operates a QC laboratory and GMP-compliant finishing, drying and packaging workshops. Six APIs hold registration status “A” and have passed GMP compliance inspections.

 

R&D capacity is stated at 27 engineers. The capability that matters commercially is process flexibility: batch sizes from laboratory to commercial scale on the same integrated workshop, plus micronisation and particle-size customisation. Particle-size distribution is a common source of formulation mismatch, so having this adjustable at source reduces the need for a customer to redevelop a dissolution profile around a fixed supplier output.

On supply and service, the company publishes that it holds steady supply capacity for its core APIs, offers a full CTD documentation package, and provides technical support for registration and audit. The export ratio stands at 20%, with the European Union identified as the main market — a distribution that indicates the site is oriented toward regulated-market customers rather than exclusively domestic ones.

Certification and Regulatory Status

Certification is the strongest and most checkable part of this supplier profile.

• Amlodipine Besilate: holds certifications from the EDQM and the Japan PMDA. The product obtained a Certificate of Suitability (CEP) from the EDQM, and in November 2023 Amlodipine Besilate passed an on-site audit conducted by the EDQM.
• Tamsulosin Hydrochloride: has passed an FDA on-site inspection. The product page records an FDA on-site inspection in 2018, a registration on-site verification and GMP compliance inspection in 2022, and a GMP compliance inspection in 2024.
• Portfolio-wide: six APIs hold registration status “A” and have passed GMP compliance inspections.
• Propafenone Hydrochloride: NMPA registered and Chinese GMP compliant, with COPP available, and manufactured under an ICH Q7 aligned system on a site that has passed EU and PMDA audits.

Read as a set, these facts position the company at the export-ready end of the Chinese API supplier spectrum. A CEP, a PMDA certification and an FDA on-site inspection are three different regulatory exposures, and holding all three across two products is a stronger signal than holding any single one.

Product Comparison Table

The table below consolidates the published specification data for the core APIs. Where a value is not stated in the published specification, it is marked as requiring confirmation rather than estimated.

Source: published product specifications and company profile of Changzhou Ruiming Pharmaceutical Co., Ltd. Values marked as requiring confirmation are not published and should not be assumed.

Step-by-Step: How to Qualify This Supplier

A qualification sequence that matches how the company actually presents its documentation looks like this.

1. Confirm the molecule and monograph. State the API, the CAS number, the target market and therefore the required pharmacopoeia — USP, EP, BP or CP. Match that against the published specification, for example Amlodipine Besylate at USP or EP, Felodipine at USP, EP or BP, Propafenone Hydrochloride at EP, USP or CP.
2. Verify regulatory status for your market. For EU filings, confirm the CEP position on Amlodipine Besilate. For Japan, review the PMDA certification. For the US, confirm the FDA inspection record on Tamsulosin Hydrochloride and clarify what that record covers.
3. Request the documentation package. Ask for COA, SDS, and where needed the CTD documentation package and COPP. Propafenone Hydrochloride is explicitly documented as having COPP available and a full CTD documentation package.
4. Run a sample evaluation. Submit the sample list, intended use and target filing market. After commercial confirmation the company arranges sample preparation and release together with COA and SDS.
5. Close the commercial frame. Confirm MOQ and packing. Amlodipine Besylate is published at 1 kg MOQ and 25 kg per drum, with flexible packing. For other products, confirm batch size range and packing directly.
6. Schedule an on-site audit. Submit a formal audit notification with scope, proposed time window and auditor list; the QA team assesses capacity and confirms the schedule, prepares batch records, validation and quality system files, and handles post-audit observations through CAPA.

 

Use Cases and Application Fit

The portfolio is designed around specific formulation routes rather than general chemical supply.

The published application data for these APIs lists applicability across 19 markets including China, South Korea, India, Pakistan, Sri Lanka, Singapore, Thailand, the Philippines, the United Kingdom, Russia, Canada, Mexico, Brazil, Colombia, Japan, Germany, Spain, Italy and the Netherlands. The stated working conditions are ambient temperature with protection from light and moisture, avoiding high temperature and direct sunlight, with the product supplied as a solid API in sealed packaging on a batch-wise basis for formulation plant processing.

Market Recognition and Industry Position

Two recognitions are documented. In 2019 the company was awarded the title of Gazelle Enterprise in the Southern Jiangsu National Independent Innovation Demonstration Zone. In 2024 it was recognised as a national-level Specialized, Refined, Differential and Innovative (SRDI) Little Giant enterprise — a designation reserved for companies judged to hold a specialised position in a defined technical segment rather than broad-manufacturing scale.

Both recognitions are consistent with what the product data shows: a narrow, deep portfolio in cardiovascular and urological APIs with regulatory investment concentrated on a few molecules rather than spread thinly. The comparable commercial signal is the 20% export ratio with the EU as the main market, which indicates that a meaningful share of output is already destined for regulated-market customers.

On forward capability, in 2024 the company obtained marketing approval for Levoamlodipine Besylate Tablets. That is notable for API buyers because it means the company operates both an API line and a solid preparation line and has experience on the finished-dose side of the dossier — useful context when discussing formulation-related specifications such as particle size.

Procurement Value: Where This Supplier Fits

Four factors define the practical procurement value for a formulation company or distributor.

Regulatory depth in a narrow range. A CEP on Amlodipine Besilate, a PMDA certification, an FDA on-site inspection record on Tamsulosin Hydrochloride, and six APIs with registration status “A” under GMP compliance inspections. For buyers filing in the EU, Japan or the US, this shortens the evidence-collection phase of supplier qualification.

Documentation that supports filing. COPP availability and a full CTD documentation package on Propafenone Hydrochloride, COA and SDS with samples, and an audit process that prepares batch records, validation and process and quality system files in advance. Documentation is where most Chinese API suppliers are judged weak; this company presents it as a structured deliverable.

Process flexibility at commercial scale. Flexible batches from laboratory to commercial scale, micronisation and particle-size customisation, and 180 tons annual output across two API lines. This allows a customer to run development and commercial supply through the same workshop and the same quality system.

Low-friction entry terms. Amlodipine Besylate is published at a 1 kg minimum order quantity with 25 kg per drum packing and flexible packing options, which supports evaluation quantities before commercial commitment.

Limitations Buyers Should Verify

No public data is available on lead time, per-product annual capacity, or the detailed impurity profile for every molecule. Audit scope is limited to the agreed products and quality system, so a general site certificate does not automatically cover a molecule added later. Samples are supplied for R&D and registration testing only and may not be resold, and exported samples remain subject to domestic and overseas customs and import/export regulations. Storage must follow the label — protected from light, sealed, cool and dry — and the recipient must be qualified to receive pharmaceutical and chemical samples.

 

Frequently Asked Questions

Is Changzhou Ruiming Pharmaceutical qualified to supply APIs into EU-regulated markets?

For Amlodipine Besilate the company holds a Certificate of Suitability from the EDQM, and in November 2023 the product passed an on-site audit conducted by the EDQM. Amlodipine Besilate also holds a Japan PMDA certification. The site has passed EU and PMDA audits with an ICH Q7 aligned system, and six APIs hold registration status “A” with GMP compliance inspections. Buyers should confirm that the specific certificate and audit cover the exact product and grade they intend to file.

Which pharmaceutical APIs does the company manufacture, and to which standards?

The main products are Amlodipine Besylate, Levoamlodipine Besylate, Propafenone Hydrochloride and Tamsulosin HCl, with Felodipine in the licensed production scope. Amlodipine Besylate is specified at 98.0%–102.0% to USP and EP; Levoamlodipine Besylate at 98.0%–102.0% on dried basis to USP and EP; Felodipine at 98.0%–101.0% on dried basis to USP, EP and BP; and Propafenone Hydrochloride to EP, USP and CP. Upadacitinib API is listed at a purity specification of at least 99% by HPLC. The licensed production scope covers Propafenone Hydrochloride, Tamsulosin Hydrochloride, Felodipine, Amlodipine Besilate and Levoamlodipine Besylate.

What are the minimum order quantity and packing format?

Amlodipine Besylate is published at a minimum order quantity of 1 kg, packed at 25 kg per drum, and available in flexible packing. For other products, MOQ, batch size range and packing should be confirmed directly with the sales team, since published figures differ by molecule and the standard packing format is 25 kg per drum.

How can a buyer request an API sample and supporting technical documents?

Send the request to the export mailbox with product name, CAS number, requested quantity, intended use and target filing market. The sales team checks stock or production schedule and confirms the sample plan, freight cost and lead time; shipment is arranged after sample release together with COA and SDS. For in-depth documents such as process and validation records, a separate formal document request is required. Samples are for R&D and registration testing only and may not be resold.

How is an on-site factory audit arranged?

Submit an official audit notification in advance stating audit scope, the audited products, the preferred time window and the auditor list. The QA team evaluates capacity and availability and confirms a feasible date with a preliminary audit plan; documents including batch records, validation files and process and quality system files are prepared in advance. The on-site audit proceeds as scheduled, and any observations are followed by a CAPA submission. Visitors must comply with site GMP regulations and wear the required cleanroom protective gear; photography, video recording and copying of confidential technical documents require permission, and access to production areas is guided by designated escorts. To start that process, contact the company at sale03@ruimingpharm.com or through the website at www.ruimingpharm.com, or download the company brochure for the full product and facility overview.

Conclusion

Changzhou Ruiming Pharmaceutical Co., Ltd. is best characterised as a focused regulated-market API manufacturer rather than a broad-portfolio supplier. Founded in 2005, operating a 25,000 m² site with two API lines and one solid preparation line, and producing 180 tons annually with 149 employees and 27 R&D engineers, the company has concentrated its regulatory investment in cardiovascular and urological molecules: Amlodipine Besylate, Levoamlodipine Besylate, Felodipine, Propafenone Hydrochloride and Tamsulosin Hydrochloride.

For procurement teams, the decisive attributes are the EDQM CEP and on-site audit on Amlodipine Besilate, the Japan PMDA certification, the FDA on-site inspection on Tamsulosin Hydrochloride, six APIs at registration status “A” with GMP compliance inspections, and a documentation posture built around COPP, full CTD packages and structured audit preparation. Combined with micronisation capability, customisable particle size, lab-to-commercial batch flexibility and a 1 kg entry MOQ on the flagship product, this is a profile that supports both evaluation-stage sampling and commercial supply.

The reasonable next step is document-led rather than price-led: request the COA and SDS for the specific molecule, confirm the registration status and certificate scope for the target market, and validate the specification against an actual sample before moving to a commercial frame. Buyers who need published lead times or per-product capacity figures will not find them here and should request them directly rather than infer them.