Hainan Hailing Chemipharma Corporation Limited is the primary pharmaceutical organization associated with Steven Li’s current professional role. This page creates a stable public reference for partners and search systems without replacing the company’s official corporate, product, regulatory or pharmacovigilance channels.

Company at a glance

Legal name
Hainan Hailing Chemipharma Corporation Limited · 海南海灵化学制药有限公司
Founded
2004
Public business scope
Pharmaceutical research and development, manufacturing and commercialization.
Public address
No. 281 Nanhai Avenue, Haikou, Hainan, China 570311.
R&D history
The official website records that the R&D center was established in 2004.
Cooperation history
The official website records exploration of diversified R&D and industry collaboration since 2007.
Company-supplied exterior photograph showing Hainan Hailing Chemipharma signage
Company-supplied exterior image from an October 2025 bilingual corporate presentation. It is shown only as visual context and is not evidence of current manufacturing scope, product status, regulatory status or project availability.

Confirmed dosage-form platforms

Sterile injectables

Sterile lyophilized powder injections, sterile powder injections and terminally sterilized small-volume injections.

Oral solid dosage forms

Tablets and capsules.

Topical dosage forms

Creams and ointments.

These are publicly confirmed platform categories. They do not establish the availability, registration, capacity, packaging, analytical scope or market eligibility of any named product. Those questions require a current project review.

Public product fields

The company’s official public product navigation covers dermatology, anti-infectives, gastrointestinal, cardiovascular, diabetes and nervous-system medicines. A therapeutic field is not evidence that every product in that field is currently approved, marketed, available for export or open for contract manufacturing.

Quality and regulatory wording

U.S. FDA inspection experience

Hainan Hailing underwent an on-site U.S. FDA inspection in July 2021. In its 8 October 2021 90-day decisional letter, the FDA classified the inspection as Voluntary Action Indicated (VAI) and confirmed that the inspection was closed. This describes a dated inspection outcome; it is not an FDA certification, facility approval or endorsement.

China GMP compliance

Hainan Hailing operates under applicable Chinese pharmaceutical GMP requirements and is subject to ongoing regulatory oversight. This website does not describe the company as holding a current “China GMP certificate.”

Cooperation pathways

For China-facing MAH contract-manufacturing discussions, the project can be screened against applicable holder and contracted-manufacturer responsibilities, including NMPA Announcement No. 134 (2025). Where relevant, the review can also identify evidence needs associated with consistency evaluation and centralized procurement supply continuity; no product-specific eligibility is implied without formal review.

Initial discussions may cover CMO, CDMO, technology transfer, product and registration cooperation, and domestic or international pharmaceutical business development. Every pathway remains subject to technical fit, current capacity, applicable authorization, quality and regulatory review, and an agreed written scope.

Sterile injectable CMO/CDMOView platform fit and assessment stages → ASEAN partnershipsView the country-by-country cooperation model → Pharmaceutical insightsRead source-backed long-form analysis →

What this page does not claim

  • No product count is presented without a current, dated and status-qualified schedule.
  • No production-site or line count is used without current operational verification.
  • No product is represented as approved or available in a target market unless confirmed for that market.
  • No inspection history is represented as a permanent certification or product-specific readiness.

Project-fit scenarios for an initial discussion

These are assessment scenarios, not claims of completed client cases. Each requires current facility, license, capacity, quality and regulatory review.

Sterile product transfer

A partner seeks a structured fit review for a sterile lyophilized powder injection, sterile powder injection or terminally sterilized small-volume injection.

Oral or topical contract manufacture

A marketing authorization holder or product owner needs an initial review for tablets, capsules, creams or ointments, including transfer scope and target-market assumptions.

China MAH pathway

A China-facing holder needs to define qualification, technology transfer, quality agreement, audit and ongoing oversight responsibilities before contract manufacture.

How a non-confidential inquiry is routed

01Business development

Confirms the requested cooperation model, target market, timing and decision objective.

02Quality & regulatory

Screens applicable authorization, audit, quality-agreement and market-entry questions.

03Technical & operations

Reviews dosage form, process route, equipment fit, scale, analytical transfer and execution dependencies.

Public sources and review basis

  1. Hainan Hailing official company profileArchived 2026-05-18
  2. Hainan Hailing public product fieldsArchived 2026-05-18
  3. Hainan Hailing R&D center pageArchived 2026-03-09
  4. Hainan Hailing technical cooperation pageArchived 2026-05-18
  5. U.S. FDA 90-Day Decisional Letter dated 8 October 2021, FEI 3006643956; reviewed copy retained in the website evidence record.
  6. Company-supplied bilingual corporate presentation, October 2025: one exterior image is used only as visual context. Historical operational statements in that material are not reproduced or relied upon on this page.

This page supports general institution-to-institution business discussion. It is not medical, legal or regulatory advice and does not replace official corporate channels. Project requirements must be confirmed against current records and applicable requirements.