Foreign Investor FeasibilityKBLI 21011
§ 01
Foreign investment rules
Indonesia's BUPM (Investment Business Fields) regulation places this code into one of five tracks. The track determines whether a foreign investor (PMA) can operate in this activity at all, and under what conditions.
Status · open
Open under BUPM (subject to sector rules)
KBLI 21011 is not on Indonesia's closed, conditional, SME-reserved, or partnership-required schedules under BUPM (Pres. Reg. 10/2021). A foreign investor can incorporate a PT PMA under this code, but sector regulators (PSE/Kominfo, BPOM, OJK, Kemenkes, Permendag, ESDM) almost always add licensing and capital requirements on top — the practical answer depends on your specific business model.
This KBLI is open under BUPM (Pres. Reg. 10/2021) — it's not on any restricted, closed, SME-reserved, or partnership-required schedule. That's the BUPM verdict only, not a complete sector-readiness check: sector regulators almost always add requirements on top (PSE/Kominfo for digital platforms, BPOM for food and cosmetics, OJK for financial, Kemenkes for healthcare, Permendag for retail, ESDM for energy). BKPM's default capital floor is IDR 2.5 billion paid-up with IDR 10 billion+ total investment commitment per KBLI, but sector regulators frequently set higher minimums for specific activities. The practical answer depends on your business model — confirm with our team before committing capital.
Tax incentives
Foreign-investor tax benefits available for this KBLI under PMK 130/2020 (Tax Holiday) and PP 78/2019 (Tax Allowance). Both require approval — see the linked guide for the application path.
Eligible for Tax Holiday
100% corporate income tax exemption for 5-20 years, plus 2 additional years at 50%. Tier scales with capex (IDR 100b minimum). Pioneer industry: Pharmaceutical raw materials.
Sector capital requirement
Higher minimum capital required by BPOM / Kemenkes
Pharmaceutical manufacturing (CPOB facilities)
Required paid-up
No fixed minimum, but GMP-compliant facility build typically IDR 50-100 billion+
Regulation
PMK 26/2018 (Pelayanan Perizinan Berusaha Terintegrasi Sektor Kesehatan)
Note. CPOB certification is the binding gate, not a flat capital number — meaningful capex needed for clean-room facility build.
BKPM Reg. 5/2025's default is IDR 2.5 billion paid-up + IDR 10 billion commitment per KBLI. The figure above is the binding override for this activity — the higher number wins.
§ 02
Halal certification
Indonesia requires BPJPH Halal certification for an expanding range of consumer-product categories. This KBLI's activities fall in scope — see what's required and when.
BPJPH certification required
Halal certification is rolling in for pharmaceuticals.
OTC pharma mandatory by October 2029
OTC pharmaceuticals must hold Halal certification by October 2029; prescription drugs follow by 2034. The bar for pharma is high — every excipient, gelatin source, and processing aid must trace back to Halal-certified suppliers. Plan an 8-12 month certification project. We coordinate BPJPH alongside the BPOM marketing authorisation that any pharma product needs anyway.
- 01
Audit & gap analysis
Review your formulation, supply chain, and facility against BPJPH criteria. Identify ingredients or processes that need swapping.
- 02
LPH inspection
An accredited Halal Inspection Body (LPPOM-MUI is the largest) audits the facility and reviews documentation.
- 03
BPJPH issuance
The Halal certificate is issued under the BPJPH register and the Halal label can be applied to packaging.
Halal certification is a core Emerhub service. We've handled BPJPH projects for foreign-brand food, cosmetics, and pharma operators across Indonesia — including supply-chain re-sourcing where needed. Bundle it with your PT PMA setup and we coordinate both timelines.
Talk to a Halal advisor§ 04
How we handle your KBLI 21011 setup
Emerhub is a corporate-services provider in Indonesia. We do the legal and regulatory legwork for foreign investors so you can focus on the business itself. Here's what the engagement looks like.
§ 07
Licensing requirements in detail
Specific permits, application requirements and ongoing obligations vary by business scale and the sub-activity within this KBLI. We file these on your behalf — this section is for transparency on what we'll be handling. Switch between scales below; by default we show Large (the PMA scale).
What's required to operate
NIB
Preparation only — additional permit needed below
Operating License (Izin)
Important: NIB is issued for the preparation stage. Commercial operation requires a full Operating License (Izin) issued by the competent ministry after a substantive review of the operator's capability, facility, and compliance. Operating with NIB alone exposes the entity to penalties, blacklisting, and contract invalidation.
Processing time
7Days
Statutory turnaround
Application requirements
6Documents and capabilities you must demonstrate at registration
- 01Have a document outlining the plan for the type, specifications, quantity, and source of raw materials, as well as the source and amount/volume of energy and water needed to carry out industrial business activities for 1 (one) production cycle or for a duration of 6 (six) months ahead.
- 02Possess documents in the form of: a. Machine specifications and/or equipment list b. Photos of machines/equipment c. Sales/rental agreement that proves: 1) Control (ownership/rental) of machines for producing pharmaceutical products and quality testing equipment 2) Compliance of installed production capacity with business data
- 03Have a human resources organizational structure document that includes at least: a. Company leadership b. Production and/or quality control department c. Marketing department
- 04Have flowchart documents for: a. Procurement, receipt, and storage of raw materials, b. Production process, c. Quality control process, d. Packaging, storage, transportation, and distribution of production results.
- 05$46
- 06Possess a work agreement document that proves the employment of at least 3 (three) full-time employees as Responsible Pharmacists (APJ), with the following details: a. Production supervisor b. Quality assurance supervisor c. Quality control supervisor
Ongoing obligations
14Compliance and reporting duties throughout operation
- 01Have proof of submission of mandatory validated Industrial Data every 6 (six) months in accordance with the laws and regulations in the industrial sector.
- 02Ensure the safety and security of equipment, processes, production results, storage, and transportation, in accordance with applicable laws and regulations.
- 03Having a customer complaint/product service for: a. Adverse events b. Product quality that demonstrates a minimum service commitment to customers.
- 04Possess periodic calibration documents for quality control equipment or periodic results from independent laboratory tests on the produced products.
- 05Have a document in the form of a disaster evacuation SOP, including the arrangement of workplace safety signs.
- 06Possess a Quality Management System certificate (ISO 9001).
- 07Have a safety and security SOP for: a. Storage of raw materials in the form of chemicals b. Use of machines/equipment c. Production processes
- 08The use of raw materials must adhere to the Indonesian Pharmacopoeia or other specified standards.
- 09Have a document of the Pharmacist Responsibility Statement for the Pharmaceutical Industry of Medicinal Ingredients.
- 10Submit reports on the receipt of raw materials for medicines, production realization, and distribution of medicines every quarter in accordance with the regulations in the field of drug and food supervision.
- 11Pharmaceutical industries producing narcotics, psychotropics, and/or pharmaceutical precursors are required to submit monthly reports on the realization of production and distribution of narcotics, psychotropics, and/or pharmaceutical precursors in accordance with health regulations.
- 12In the case of industries producing drugs classified as narcotics, a special production permit for narcotics must be obtained in accordance with the regulations in the health sector.
- 13In the case of importing and/or exporting narcotics, a special import/export permit for narcotics must be obtained in accordance with the regulations in the health sector.
- 14Have a Responsible Pharmacist for Distribution.
Issuing authority
The authority that issues the license depends on your situation.
| Authority | Applies when |
|---|---|
| Minister/Head of Agency | All of them |
| Minister/Head of Agency | Foreign Investment |
§ 05
Auxiliary permits (PB UMKU)
PB UMKU permits sit on top of the main NIB and Sertifikat Standar — each is issued by a different ministry, and only when a specific operational activity is performed. This KBLI carries 3 candidate permits across 2 regulators; most operations only need a handful. Emerhub maps your operation to the exact set, files them, and tracks renewals.
Pharmaceuticals
2 permitsBPOM (National Agency of Drug & Food Control). Applies to drugs, processed food, traditional medicine, cosmetics, and health supplements — produced, imported, repackaged, or distributed for human consumption. BPOM is the gating regulator; product registration is required before any commercial sale.
- Approval for the Use of Pharmaceutical Manufacturing FacilitiesPersetujuan Penggunaan Fasilitas Pembuatan Obat3 requirements7 obligationsFood and Drug Supervisory Agency
- Certificate of Good Manufacturing Practice for PharmaceuticalsSertifikat Cara Pembuatan Obat yang Baik3 requirements3 obligationsFood and Drug Supervisory Agency
Industry & Materials
1 permitMinistry of Industry. Applies to specific manufacturing activities — basic chemicals, optical/magnetic media, regulated industrial materials — that need a Ministry of Industry compliance certificate beyond the standard NIB.
Speak to Emerhub
Get your KBLI 21011 setup handled end-to-end.
Emerhub is a corporate-services provider in Indonesia. We handle PT PMA incorporation, licensing, tax registration and monthly compliance — so you focus on operating the business.