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Jiangsu Shuanglin Marine Biological Pharmaceutical Co., Ltd.
Customer consultation telephone
4008-809-776
TEL:+86-513-83444258
E-mail:warren@china-shuanglin.com
ADD: No.40, Lvdong Street, Lvsi Marine Economic Development Zone, Jiangsu, China
Notice on Pharmaceutical GMP Compliance Inspection
Shenjia Hydraulic
Release time:
2026-03-10
In conjunction with the previously provided “Notice of Approval for Re‑Registration of Chemical Active Pharmaceutical Ingredients,” this new document, the “Notification on GMP Compliance Inspection for Pharmaceuticals,” further strengthens Jiangsu Shuanglin Marine Bio‑Pharmaceutical Co., Ltd.’s compliance barriers and quality endorsement for the product “Glucosamine Sulfate Potassium Chloride.”
The following are the core points of this notice and an analysis of its added value when combined with the re-registration approval:
1. File Basic Information
Document Type: Official Notification of GMP Compliance Inspection Results (No.: Su Yao Jian Yao Sheng Gao Zhi (2026) No. 079).
Issuing Authority: Jiangsu Provincial Drug Administration.
Date of Issuance: March 9, 2026.
2. Check the core content.
Inspected entity: Jiangsu Shuanglin Marine Bio‑Pharmaceutical Co., Ltd.
Inspection Address: No. 40, Lvdong Street, Lüsi Marine Economic Development Zone, Jiangsu (completely consistent with the address on the re‑registration approval document, indicating that the production site has not changed and remains stable).
Scope of Inspection: Active Pharmaceutical Ingredient (Glucosamine Sulfate Potassium Chloride).
Specific production line: Raw Material Pharmaceutical Workshop in Building 2, Glucosamine Sulfate Potassium Chloride (clearly designated as a dedicated workshop/production line).
Inspection Basis: Good Manufacturing Practice for Pharmaceutical Products (Revised in 2010).
Inspection period: December 19, 2025 – December 21, 2025.
Conclusion: Meets the requirements.
3. Core Value Analysis (Synergies with the Re-registration Approval)
If the re‑registration approval addresses the legal “can we sell?” question, then this GMP Notification resolves the quality compliance issue of “can we manufacture?”
Dimension | Re-registration Approval Notice | Notice of GMP Compliance Inspection | Added Value |
Legal Level | Proof that this pharmaceutical product is legal and can be sold domestically. | Verify that the drug’s manufacturing site is legal and compliant with the quality management system. | Holding both certifications simultaneously indicates that the product complies with regulations across the entire chain—from the approval number to the production process—and is therefore the preferred choice for pharmaceutical manufacturers to procure. |
Market Level | Customers (downstream pharmaceutical manufacturers) can purchase this product. | Customers (downstream pharmaceutical manufacturers) can confidently use this product in formulation production without the need for on-site audits (or with streamlined audits). | For downstream formulation companies, this means zero‑risk procurement. Especially under the associated review and approval system, using APIs that have passed GMP compliance inspections will make formulation registration much smoother. |
Time Limit Aspect | Valid until February 25, 2031. | The inspection was conducted in December 2025, and the conclusions were issued in March 2026, representing the most recent on-site inspection results. | Proof that the company has maintained a high standard of production compliance in recent months (by the end of 2025), with no decline in equipment, personnel, or processes. |
Production Level | The packaging specifications and expiration date have been clarified. | The specific production workshop (Raw Material Pharmaceutical Workshop in Building 2) has been identified, and a direct link has been established between product types and production lines. |
4. Summary
This GMP notification is the “perfect partner” for the previous re-registration approval:
Identity + Quality: Re-registration gave it “household registration,” while GMP awarded it a “Certificate of Excellent Quality Inspection.”
For customers: Upon reviewing these two documents, it’s safe to say that Jiangsu Shuanglin is one of the most compliant and reliable suppliers for this product.
For businesses: Before 2031, as long as no major changes or recalls occur, all regulatory hurdles for the production and sale of this product will have been cleared.
One additional point: The bottom of the notice mentions the rights to file for administrative reconsideration and administrative litigation. This is a standard administrative notification procedure, indicating that the document is formal and traceable, with no procedural defects whatsoever.
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