Pharmaceutical Products for Humans
Last updated · Sourced from OSS Indonesia
This group includes the manufacturing and processing of medicines, health supplements/food, in finished forms (preparations) for humans, such as tablets, capsules, ointments, powders, solutions, parenteral solutions, and suspensions, hormonal contraceptives, radio-pharmaceutical production industry, and biotechnology pharmaceutical industry.
Operating license routes through Ministry of Health (Kemenkes) / BPOM, not OSS — Emerhub handles the application end-to-end.
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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.
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.
KBLI 21012 is not on Indonesia's closed, conditional, SME-reserved or partnership-required schedules. A foreign investor may incorporate a PT PMA with up to 100% foreign ownership and operate in this activity directly.
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.
Pharmaceutical manufacturing (CPOB facilities)
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.
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.
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.
We confirm KBLI 21012 is the right primary code for your business, advise on secondary codes you may also need, and finalize the holding structure with you before any filing.
We draft the Articles of Association before a notary, register the entity with the Ministry of Law & Human Rights (Kemenkumham), and obtain the company's tax ID (NPWP). Under BKPM Reg. 5/2025, paid-up capital is IDR 2.5 billion (~USD 160K) — the cash actually deposited at incorporation. The IDR 10 billion+ figure many sources still cite is the total investment commitment per KBLI, realised over time via your LKPM reports.
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).
Documents and capabilities you must demonstrate at registration
Compliance and reporting duties throughout operation
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 |
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 23 candidate permits across 1 regulator; most operations only need a handful. Emerhub maps your operation to the exact set, files them, and tracks renewals.
BPOM (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.
We file the OSS application with KBLI 21012 as your primary business activity, complete the risk-based assessment, and collect the NIB (Business Identification Number) for you — typically within hours of submission. You don't need to touch the OSS portal.
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. We prepare the application bundle, liaise with the competent ministry, and chase issuance through to the certificate. Statutory turnaround: 7 business days — real-world timing typically runs longer when site inspections or additional clarifications are requested.
Post-launch we run your monthly tax filings, quarterly LKPM (Investment Activity Reports), annual general meeting (RUPS), and any sector-specific reporting. You get a single point of contact and a monthly compliance digest — no Indonesian-language paperwork on your desk.
› This code relates to the importation of pharmaceutical products that are essential for handling the COVID-19 pandemic.
› This code is relevant due to the importation of medical devices included in the customs and tax facilities.
› This code is affected due to the distribution of pharmaceuticals that include narcotics, requiring adherence to updated regulations.
› This code is affected due to the regulation's impact on the production and distribution of pharmaceutical products.
› This code is impacted due to the regulation's effect on the distribution and licensing of pharmaceutical products containing narcotics.
› This code is affected due to the need for compliance with new regulations on the categorization of medicines.
› This code is relevant for the wholesale distribution of pharmaceuticals, which includes psychotropic substances.
› This code is affected because it involves the wholesale of pharmaceuticals that must adhere to the new regulations on narcotics.
› Pharmaceutical companies must comply with the governance and operational procedures outlined in this regulation.
› This code is relevant for the distribution of pharmaceuticals, which includes psychotropic substances.
› This code is impacted as it includes biological products that must comply with halal certification.
› This code is impacted due to the importation of vaccine raw materials that previously benefited from tax exemptions.
› This code is relevant due to the importation of vaccine raw materials.
› This KBLI is affected as it includes the production of traditional medicines that may utilize precursors.
› This code is relevant due to the regulation's focus on the manufacturing processes and compliance requirements for plasma-derived medicines.
› This code is relevant for the distribution of pharmaceutical products, including those regulated under the Annual Needs Plan.
› This KBLI is impacted due to its involvement in the wholesale distribution of pharmaceutical products, which includes psychotropic medications.
› Entities involved in the production of narcotics must adhere to the updated control measures.
› Facilities involved in the fractionation process must adhere to specific standards for the production of biological products under this regulation.
› This KBLI is impacted due to the regulation of psychotropic substances in pharmaceutical manufacturing.
› Large pharmaceutical traders are required to obtain distribution licenses and adhere to storage standards.
› This code relates to pharmaceutical manufacturing, which is impacted by the regulation's requirements for import permits.
A plain-English explanation of this classification and the businesses it covers.
KBLI 21012 (Pharmaceutical Products for Humans) is the 5-digit Indonesian Standard Industrial Classification code for pharmaceutical products industry for humans. It sits within Manufacturing Industry under the subgroup Pharmaceutical and Chemical Medicinal Product Industry (major group 21) in the official KBLI 2020 taxonomy maintained by Statistics Indonesia (BPS).
Any Indonesian or foreign-owned entity that intends to operate in pharmaceutical products industry for humans as a primary or secondary business activity must select this code on its NIB (Business Identification Number). The selected code determines the licensing instruments required, the issuing authority, and the ongoing compliance obligations.
Indonesia's OSS Risk-Based Approach uses the KBLI code to determine three things: (1) whether foreign investment is permitted and at what cap, (2) the risk-based licensing instruments required, and (3) the authority that issues each instrument. Choosing the wrong code can delay or invalidate your license.
Indonesia's BPS published the new KBLI 2025 taxonomy in early 2025. OSS, BKPM and the operating ministries have not yet adopted it — KBLI 2020 remains the active standard for business registration. This is what's coming for this specific code.
KBLI 21012 retains the same code number and scope in the new taxonomy. The activity description, hierarchy, and intended use of the code are preserved.
When OSS adopts KBLI 2025, we'll migrate your existing entity to the appropriate successor code as part of ongoing compliance — no action needed on your end now.
Talk to a specialistIndonesia's OSS Risk-Based Approach assigns a separate risk level for each of the four business scales. The licensing instruments required (NIB, Standard Certificate, Operating License) are determined by the risk level. Foreign-owned entities (PT PMA) must register at the Large scale, so the rightmost column applies to most foreign investors.
KBLI 21012 (Pharmaceutical Products for Humans) is the 5-digit Indonesian Standard Industrial Classification code for pharmaceutical products industry for humans. It sits within the Manufacturing Industry category in the official KBLI 2020 taxonomy maintained by Badan Pusat Statistik (BPS).
Yes — KBLI 21012 is fully open to foreign investment. A PT PMA may operate with up to 100% foreign ownership, subject to BKPM Reg. 5/2025 capital requirements (IDR 2.5 billion paid-up + IDR 10 billion+ commitment per KBLI).
KBLI 21012's risk levels per business scale: Micro High, Small High, Medium High, Large High. Foreign-owned entities (PT PMA) must register at the Large scale.
NIB + Operating Licence (Izin). KBLI 21012 is High risk at Large scale, so the Operating Licence requires substantive sector-regulator approval before the business can operate. Expect a multi-month review with technical submissions. 23 sector-specific PB UMKU permits also apply depending on the exact activity. See the requirements summary at the top of the page.
Sector regulator override: No fixed minimum, but GMP-compliant facility build typically IDR 50-100 billion+ required by BPOM / Kemenkes under PMK 26/2018 (Pelayanan Perizinan Berusaha Terintegrasi Sektor Kesehatan). This is higher than BKPM Reg. 5/2025's default IDR 2.5 billion paid-up; the higher number wins.
PT PMA setup typically takes 4-8 weeks: AHU registration (1-2 weeks), NIB issuance via OSS (immediate to 1 week), bank account opening (2-4 weeks). The licensing cycle for KBLI 21012 specifically takes 7 days at the Large business scale.
Yes — KBLI 21012 is on the Tax Holiday pioneer-industry list (PMK 130/2020) under Pharmaceutical raw materials. Eligible for 5-20 year corporate income tax exemption depending on capex tier.
Authority depends on the investor profile. For PMA: Minister/Head of Agency. For domestic SME scale: typically Governor (for Provincial scope) or Regent/Mayor (Regency/City scope). Specific mapping is in §1 of this page.
Beyond the NIB, KBLI 21012 carries 23 PB UMKU permits across 1 sector regulator: Pharmaceuticals (23). Most operations only need 2-4 of these — the relevant set depends on which specific activities you actually perform; Emerhub maps the right subset before filing.
KBLIs in the same subgroup 2101: 21011 (Pharmaceutical Materials Industry for Humans); 21013 (Animal Pharmaceutical Industry); 21014 (Pharmaceutical Industry for Animals); 21015 (Medical Devices Industry in Subgroup 2101). These are closely related activities — see the related-codes section below for full list.