21012Pharmaceutical Products Industry for Humans
Pharmaceutical Products for Humans
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.
Key facts for KBLI 21012
The essentials a foreign investor needs to know before reading the rest of this page.
100% foreign ownership permitted via PT PMA. KBLI 21012 is not on Indonesia's closed, conditional, SME-reserved or partnership-required schedules under Pres. Reg. 10/2021.
Default minimum paid-up capital: IDR 2.5 billion (~USD 160K) under BKPM Reg. 5/2025 (effective Oct 2025) — applies unless a sector regulator sets a higher figure for this activity. The often-cited IDR 10 billion is the total investment commitment per KBLI realised over time via quarterly LKPM reports, not required upfront.
High-risk activity — requires NIB + full Operating License (Izin) to operate commercially. NIB alone enables only the preparation stage; an Operating License must be obtained before invoicing or production starts.
Statutory licensing turnaround: 7 days once we submit the application — on top of the 2–3 weeks for PT PMA incorporation. We coordinate the full sequence end-to-end.
Issuing authority for PMA: Menteri/Kepala Badan — specific to foreign-owned entities under this KBLI.
BPOM registration mandatory: a separate Indonesian FDA marketing authorization (NIE) is required before any product is marketed. Facility must be CPOB-certified.
Ongoing reporting: quarterly LKPM (Investment Activity Report) to BKPM plus 13 sector-specific obligations. We file these on your behalf as part of monthly compliance — you stay out of the OSS portal entirely.
- Risk level
- HighNIB + full Operating License
- Primary license
- NIB + full Operating License (Izin)NIB enables preparation only — additional permit needed to operate
- Setup timeline
- 7 DaysStatutory turnaround at OSS
- Issuing authority
- Minister / Agency HeadFor foreign-owned (PMA) entities
- Min. paid-up capital
- IDR 2.5 BBKPM default paid-up — sector rules may set a higher figure
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.
Fully open to foreign investment
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.
How we handle your KBLI 21012 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.
- 1
Confirm the optimal structure for your business
2–3 business daysWe 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.
What we need from you- Founders' passport copies and proof of residence
- Intended share split and board composition
- 2
Incorporate your PT PMA
7–10 business daysWe 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.
What we need from you- Powers of attorney (we prepare; you sign and notarize)
- Director / commissioner appointment letters
- Initial capital deposit confirmation
- 3
We obtain your NIB
1–2 business daysWe 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.
What we need from you- Office address (virtual office acceptable for many KBLIs; we can arrange one)
- 4
Secure your full Operating License (Izin)
7+ business daysNIB 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.
What we need from you- Technical documentation specific to your operation
- Appointment of a Penanggung Jawab Teknis (PJT — technical responsible person)
- 5
Hand-off to ongoing compliance
OngoingPost-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.
What is KBLI 21012?
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 in the official KBLI 2020 taxonomy maintained by Statistics Indonesia (BPS).
Who needs KBLI 21012?
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.
Why does the code matter?
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.
Pharmaceuticals-specific guidance
Sector context that applies to KBLI 21012 beyond the generic OSS process. Verify with the relevant ministry before committing capital.
- ·Production licenses (Izin Industri Farmasi) are issued by BPOM and require CPOB-certified facilities.
- ·Traditional medicine (jamu / obat tradisional) production is restricted to 100% Indonesian ownership.
- ·Pharmaceutical product registration (NIE Obat) typically takes 12–18 months.
Under the upcoming KBLI 2025
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.
Carried forward into KBLI 2025
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.
- ·Continue using 21012 for current registrations under KBLI 2020.
- ·When OSS adopts KBLI 2025 (timing not yet announced), no migration is required for this code.
- ·Risk level, permits, and authority routing shown above remain in effect under both taxonomies.
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 specialistRisk level by business scale
Indonesia'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.
Micro
Small
Medium
Large
PMA scaleWhat does each risk level require to operate? ›
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).
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
- 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.
- 09Possess a document of the Pharmacist's Statement of Responsibility for the Pharmaceutical Industry.
- 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. Foreign investors typically fall under Minister/Head of Agency · PMA.
| Authority | Applies when |
|---|---|
| Menteri/Kepala Badan | All of them |
| Menteri/Kepala Badan | PMA |
Auxiliary permits (PB UMKU)
This KBLI commonly carries 46 additional permits attached to specific operational activities. PB UMKU permits are issued separately from the main business license — apply only for the ones relevant to your operation.
- Approval for Shared Use of Drug Facilities to Produce Non-Drug Products.approval-for-shared-use-of-drug-facilities-to-prod
- Approval for the Implementation of Bioequivalence Testing.approval-for-the-implementation-of-bioequivalence-
- Approval for the Implementation of Cosmetic Clinical Trials.approval-for-the-implementation-of-cosmetic-clinic
- Approval for the Implementation of Drug Clinical Trials.approval-for-the-implementation-of-drug-clinical-t
- Approval for the Implementation of Health Supplement Clinical Trials.approval-for-the-implementation-of-health-suppleme
- Approval for the Implementation of Preclinical Testing for Quasi-Drugs.approval-for-the-implementation-of-preclinical-t-2
Get your KBLI 21012 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 can focus on operating the business.
Get a quote for KBLI 21012