Pharmaceutical Ingredients for Humans
Last updated · Sourced from OSS Indonesia
This group includes the manufacturing and processing of medicinal materials, auxiliary materials, and packaging materials for humans, derived from chemical substances, natural materials, animals, and plants, including those from biological sources, such as medicinal products, antisera, and other blood fractions, vaccines, and homeopathic preparations. It includes the active pharmaceutical ingredient industry (antibiotics, vitamins, salicylic acid, and o-acetylsalicylic acid, among others) for pharmacological materials in the pharmaceutical industry, blood processing, pure chemical sugar industry, gland processing, gland extraction industry, and others.
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 21011 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.
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.
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.
Review your formulation, supply chain, and facility against BPJPH criteria. Identify ingredients or processes that need swapping.
An accredited Halal Inspection Body (LPPOM-MUI is the largest) audits the facility and reviews documentation.
The Halal certificate is issued under the BPJPH register and the Halal label can be applied to packaging.
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.
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 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.
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.
Ministry 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.
We confirm KBLI 21011 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.
We file the OSS application with KBLI 21011 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.
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.
› Pharmaceuticals — Phase 3 mandatory halal certification (Oct 2029 deadline)
› Pharmaceutical raw materials are recognized as a pioneer industry eligible for tax holiday.
› Mandatory halal certification applies to pharmaceutical products.
› This code involves pharmaceutical products that require halal certification for market entry.
A plain-English explanation of this classification and the businesses it covers.
KBLI 21011 (Pharmaceutical Ingredients for Humans) is the 5-digit Indonesian Standard Industrial Classification code for pharmaceutical materials 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 materials 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 21011 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 21011 (Pharmaceutical Ingredients for Humans) is the 5-digit Indonesian Standard Industrial Classification code for pharmaceutical materials industry for humans. It sits within the Manufacturing Industry category in the official KBLI 2020 taxonomy maintained by Badan Pusat Statistik (BPS).
Yes — KBLI 21011 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 21011'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 21011 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. On top of that, halal certification from BPJPH is mandatory under UU 33/2014 (OTC pharma mandatory by October 2029). Emerhub files the BPJPH application and coordinates the LPH audit on your behalf. 3 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 21011 specifically takes 7 days at the Large business scale.
Yes — KBLI 21011 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 21011 carries 3 PB UMKU permits across 2 sector regulators: Pharmaceuticals (2), Industry & Materials (1). 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: 21012 (Pharmaceutical Products 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.