for further information, please contact halopyfa@pyfa.co.id
PYFA MAH: Where regulatory mastery meets market success. We deliver compliance and confidence, every step of the way
“The Essential Partner for Seamless Pharmaceutical Market Entry in Indonesia, offering expert guidance on BPOM Regulations and Approval Pathways.”
To successfully enter the Indonesian pharmaceutical market, a drug product must secure Marketing Authorization, issued by the National Agency of Drug and Food Control, known in Indonesia as the Badan Pengawas Obat dan Makanan (Badan POM/BPOM). This institution functions as the country's equivalent of the Food and Drug Administration (FDA).
As mandated by Indonesia's rigorous Criteria and Procedures for Drug Registration, obtaining this critical Marketing Authorization is strictly contingent upon a successful and compliant registration process with the BPOM.
This article details the essential steps and regulatory pathway required for registering a pharmaceutical drug in the Republic of Indonesia.
MAH has deep expertise in managing various types of pharmaceutical products, from highly complex originator/ innovator drugs to widely distributed generics.
1
Extensive Experience in Pharmaceutical Products
PYFA MAH has broad expertise in handling both originator/innovator and generic products.
- Originator/innovator products require a complex registration process, including patent verification (local and international) and comprehensive quality documentation. Our in-depth knowledge ensures smooth regulatory submission.
- Generic products are derived from originators, offering more affordable prices and simpler packaging, while still fully complying with regulatory requirements.
2
Regulatory Expertise
We are highly familiar with the latest regulations, documentation formats, and technical guidelines issued by the Ministry of Health and BPOM. This allows us to:
- Prepare complete and accurate dossiers
- Anticipate and prevent compliance issues
- Accelerate the approval process while maintaining regulatory integrity
3
Proven Track Record of Success
With more than 5 years of experience as a Marketing Authorization Holder (MAH) service provider, PYFA MAH has:
- Successfully registered 60+ SKUs across multiple therapeutic areas
- 30+ additional SKUs currently in progress Our consistent results reflect our reliability, efficiency, and commitment to client success.
4
International Standards & Certifications
We operate in accordance with globally recognized quality and manufacturing standards, including:
- CPOB / GMP (Good Manufacturing Practice) – Ensuring safety, consistency, and product reliability
- ISO 9001 – Demonstrating our commitment to continuous improvement and operational excellence
5
Dedicated Pharmacovigilance (PV) Team
Patient safety is our top priority. Our experienced PV team:
- Continuously monitors product performance in the market
- Collects, evaluates, and reports adverse drug reactions
- Ensures compliance with post-marketing surveillance requirements This proactive approach maintains public trust and supports long-term product sustainability.
Our Partners
PYFA MAH: Your single point of access to the Indonesian market. We handle the regulation, the logistics, and the growth
Marketing Authorization (MA) Holder
PYFA acts as the official Marketing Authorization Holder, allowing external principals to legally market and distribute their pharmaceutical products in Indonesia under the PYFA company name. This minimizes regulatory risk and speeds up market entry.
Product Registration with BPOM
We manage the entire product registration process—from dossier preparation and document submission to follow-up with BPOM—until the product receives its official Marketing Authorization Number (NIE). Our regulatory expertise ensures accuracy, compliance, and faster approval.
Importation Services
PYFA provides end-to-end importation support for pharmaceutical and healthcare products. We handle all permits, documentation, customs clearance, and regulatory compliance to ensure smooth and lawful import from overseas.
Co-Marketing & Commercial Support
For principals without a dedicated marketing team, we offer customized distribution, promotion, and branding strategies tailored to the Indonesian market. We support market access, product positioning, and sales growth.
Secondary & Repackaging Services
We provide compliant secondary packaging and repackaging services according to BPOM standards. This includes labeling, box packaging, language adaptation, and product presentation to ensure regulatory readiness and market suitability.
