Foreign Investor FeasibilityKBLI 21022
§ 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 · domestic only
Open only to Indonesian capital
100%
domestic capital
KBLI 21022 is restricted to 100% domestic ownership. Foreign investors cannot hold shares in entities operating under this code. This restriction commonly applies to traditional industries, broadcasting, and culturally significant activities.
Listed restrictions
Conditional sub-activities
1- Traditional medicine product industry for humansDomestic only100% Domestic capital
Reserved for SMEs / cooperatives
1Tax 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 Allowance
30% reduction of taxable net income over 6 years, accelerated depreciation, 10-year loss carryforward. Mutually exclusive with Tax Holiday.
Note. Pharmaceutical manufacturing (KBLI 21xxx) is on the PP 78/2019 Tax Allowance priority list.
§ 02
Pharmaceuticals-specific guidance
Sector context that applies to KBLI 21022 beyond the generic OSS process. Verify with the relevant ministry before committing capital.
Lead regulator
Ministry of Health (Kemenkes) / BPOM
- ·CPOB (Good Manufacturing Practice) certification mandatory for all production facilities.
- ·BPOM Distribution Permit (NIE) required for each product SKU.
- ·Foreign equity in branded pharmaceuticals open up to 100%; generic drugs may have local-partner requirements.
- ·Vaccine manufacturing strategically protected; foreign participation often via JV with Bio Farma.
§ 03
Regulations governing KBLI 21022
Current status, what each regulation actually requires for this activity, and how it ties to the PB UMKU sector permits below. Click through for the plain-English summary.
- Ministry of Investment / BKPM
- Ministry of Finance
- President of the Republic of Indonesia
§ 04
Common business profiles under KBLI 21022
Archetypal businesses operating under this code. Use these to recognize whether your venture maps to KBLI 21022 as primary or secondary activity.
What businesses register under KBLI 21022?
Real-world business archetypes — names omitted; profiles describe operational shape, not specific companies.
- 01Foreign generics manufacturer
Multinational pharma operating Indonesian production facilities for ASEAN-distributed generic drugs.
- 02
§ 02
What this means for foreign investors
An honest read of the situation, plus the structures that work in practice. We've handled all of these — book a call to walk through your specific plan.
You can't hold equity in this activity directly.
This KBLI is reserved to 100% Indonesian capital under Pres. Reg. 10/2021. Foreign investors cannot own shares in an entity registered for this code. The honest paths forward are: (1) operate a different but related KBLI that's open to PMA, (2) partner with a fully Indonesian-owned licensee under a commercial / IP / supply agreement (not equity), or (3) explore a Special Economic Zone where the rule may be relaxed.
Pathways that work
Move to a different value-chain step
The cleanest path: operate a related but open KBLI. For example, foreign investors blocked from primary commodity production frequently succeed with the processing, distribution, branding, or export-trade codes upstream or downstream of the restricted activity.
Special Economic Zone (KEK) or Free Trade Zone (Batam)
Several restricted codes have higher or full PMA caps inside designated KEK zones (Sanur Health, Lido, Mandalika) or the Batam Free Trade Zone — manufacturing, logistics, and IT services especially. The IUK regime under BP Batam relaxes ownership rules selectively in exchange for export orientation. We assess whether your operation can benefit. See the for the requirements.
Indonesian-owned operating company + commercial agreement
A 100% Indonesian-owned operating entity can hold the restricted licence while you contract with it commercially. We structure these arrangements deliberately — without nominee shareholding, which is unenforceable and increasingly scrutinised.
PMA-viable codes in the same area
These siblings are usable by a foreign-owned PT PMA — they have a Large-scale licensing matrix and aren't on a restricted list. Each has its own context badge so you can pick by trade-off.
Restricted KBLIs need a tailored structure. Book a call and we'll map the right entity, partner, and licensing path for your specific business.
Talk to a corporate-services specialist§ 08
Reference data: how this KBLI is regulated
The data below is the official OSS regulatory profile for this code. It applies to qualifying Indonesian operators (or to your operating partner). Foreign investors won't file these directly, but it's useful context when structuring a partnership or commercial arrangement.
Foreign investors:the licensing matrix below is for context only — direct PMA registration isn't possible for this code. See pathways above for what actually works.
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 a flowchart document 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
- 06Have a document of a statement of ownership from the Responsible Pharmacist (APJ) with the qualification of a Pharmacist who works full-time, at least 1 (one) person.
Ongoing obligations
10Compliance 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 Herbal Pharmacopoeia or other specified standards.
- 09Have a document of the Certificate of Pharmacist Responsible for Natural Medicine Industry.
- 10Submit product distribution reports every 6 (six) months in accordance with the regulations in the health sector.
Issuing authority
The authority that issues the license depends on your situation.
| Authority | Applies when |
|---|---|
| Minister/Head of Agency | The industrial location is situated within a cross-border area between provinces. |
| Minister/Head of Agency | Foreign Investment |
| Governor | The industrial location is in the relevant province. |
§ 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 25 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
24 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 Quasi Drug AdvertisingPersetujuan Iklan Obat Kuasi2 requirements1 obligationFood and Drug Supervisory Agency
- Approval for the Implementation of Clinical Trials for Health SupplementsPersetujuan Pelaksanaan Uji Klinik Suplemen Kesehatan2 requirements6 obligationsFood and Drug Supervisory Agency
- Approval for the Implementation of Clinical Trials for Quasi DrugsPersetujuan Pelaksanaan Uji Klinik Obat Kuasi2 requirements6 obligationsFood and Drug Supervisory Agency
- Approval for the Implementation of Clinical Trials for Traditional MedicinePersetujuan Pelaksanaan Uji Klinik Obat Tradisional2 requirements6 obligationsFood and Drug Supervisory Agency
Veterinary & Animal Medicine
1 permitMinistry of Agriculture. Applies if you produce, import, distribute, or sell animal medicines, vaccines, or feed; if you breed livestock; or if you operate a veterinary practice. A "veterinary control number" (NKV) is the entry-point permit for animal-product processors.
Speak to Emerhub
KBLI 21022 needs a tailored structure. Let's design it.
Restricted KBLIs need a structure designed around the restriction — partnership, alternative code, KEK, or commercial arrangement. We've handled all of these. One conversation tells you what works for your plan.