Manufacture of drugs and medicines including biological products such as bacterial and virus vaccines, sera and plasma
Manufacture of drugs and medicines including biological products.
Includes
- bacterial and virus vaccines
- sera
- plasma
Excludes
- Manufacture of herb infusions (mint, vervain, chamomile etc.) (class 2100 exclusion) 1079
- Manufacture of dental fillings and dental cement (class 2100 exclusion) 3250
- Manufacture of bone reconstruction cements (class 2100 exclusion) 3250
- Wholesale of pharmaceuticals (class 2100 exclusion) 4649
- Retail sale of pharmaceuticals (class 2100 exclusion) 4772
- Research and development for pharmaceuticals and biotech pharmaceuticals (class 2100 exclusion) 7210
- Packaging of pharmaceuticals (class 2100 exclusion) 8292
Foreign ownership
This activity is not on the 12th Foreign Investment Negative List. A foreign investor may hold up to 100%, subject to the minimum-capital rules below.
Recommended route
Foreign-owned corporation
Up to 100% foreign equity (SEC)
One Person Corporation
A single foreign owner
Branch office
Extension of a foreign parent
Entity types
Which structure fits depends on your goal. Rows that suit this activity are highlighted. Open a row for the full detail.
| Structure | 100% foreign | Sell locally | No PH partner | No capital floor | No entity | Min. capital |
|---|---|---|---|---|---|---|
| Domestic corporationFits | ✓ | ✓ | ✓ | ✕ | ✕ | USD 200k |
| One Person CorporationFits | ✓ | ✓ | ✓ | ✕ | ✕ | USD 200k |
| Branch officeFits | ✓ | ✓ | ✓ | ✕ | ✕ | USD 200k |
| Representative officeFits | ✓ | ✕ | ✓ | ✕ | ✕ | USD 30k |
| Local corporation, minority foreign | ✕ | ✓ | ✕ | ✓ | ✕ | Lower / none |
| Employer of RecordFits | – | ✕ | ✓ | ✓ | ✓ | None |
| Product holdingFits | – | ✓ | ✓ | ✓ | ✓ | None |
Registration path
- 1
SEC
Incorporate the entity
- 2
BIR
Tax registration and books
- 3
LGU
Barangay clearance and Mayor’s permit
- 4
Regulator
Sector license, if the activity needs one
Emerhub files each step with the government; you provide the documents and information.
Minimum paid-up capital
| Situation | USD | PHP |
|---|---|---|
| Domestic-market enterprise (>40% foreign)Paid-up capital for foreign equity above 40% serving the local market. Legal basis: FIA (RA 7042 as amended). | $200,000 | ≈ ₱11.4M |
| Reduced thresholdAt least 50 direct employees, or advanced technology. Legal basis: FIA (RA 7042 as amended). | $100,000 | ≈ ₱5.7M |
| Export enterpriseExports at least 60% of output. Legal basis: Corporation Code (RA 11232). | ≈ $88 | ₱5,000 |
| Retail trade enterpriseMinimum paid-up capital for foreign retail. Legal basis: RA 11595. | ≈ $439k | ₱25,000,000 |
Bold is the figure the law sets; the other column is an approximate conversion at ₱57 to USD 1.
Licenses & product holding
Alongside SEC incorporation, this activity needs the following regulatory license or product registration before it can legally operate in the Philippines.
- FDA - product & establishment license
FDA License to Operate (LTO) + Certificate of Product Registration (CPR) - Drug/Pharmaceutical
Manufacturing drugs, medicines, biologics (vaccines, sera, plasma), or related surgical consumables (dressings, sutures) requires an FDA LTO as a drug establishment plus a CPR for each product, under RA 3720 (Food, Drug, and Cosmetic Act, as amended) and the FDA Act of 2009 (RA 9711).
Emerhub can hold this registration for you.
Incentives
This activity may be eligible for BOI/PEZA income-tax holidays and enhanced deductions under the Strategic Investment Priority Plan (SIPP), CREATE MORE.
- May qualify for Tier II
Manufacture of vaccines (vaccine self-reliance)
Legal basis: 2022 Strategic Investment Priority Plan (BOI MC No. 2022-023), Tier II - dependable health system value-chain activity
Eligibility is activity-specific and confirmed by the BOI. Emerhub can assess your activity and file your incentive application.
Mapped to the 2022 SIPP. A 2026 SIPP is now in force, so confirm current priority status with the BOI before you rely on this.