Is API Certification mandatory for all pharmaceutical exports from India?

API Certification is mandatory for exporting pharmaceutical raw materials (APIs) and bulk drugs under the FTP 2023-28 and FTDR Act regulations. Exporters shipping to regulated markets (USA, EU, Canada) face stricter enforcement, though domestic regulatory compliance applies universally. Non-certified exports may result in shipment detention, customs penalties (₹25,000-₹1,00,000), and loss of export privileges.

What is the validity period of API Certification?

API Certification issued by DGFT remains valid for 5 calendar years from the date of issuance. Renewal applications must be submitted 90 days before expiry through the ITMS portal. Non-renewal results in de-listing from approved exporter databases and suspension of RoDTEP benefits, making it difficult to secure letters of credit from international buyers.

Can I export APIs without GMP certification if I have API Certification from DGFT?

No. API Certification from DGFT explicitly requires proof of GMP compliance through WHO-GMP, ISO 9001:2015, or equivalent certification. GMP is a mandatory eligibility criterion, and exporting from non-GMP facilities remains a violation of FTP 2023-28 and attracts customs penalties under Section 112 of the Customs Act 1962.

How long does it take to obtain API Certification?

Standard processing timelines range from 30-45 days for existing manufacturers with established compliance records. Applicants requiring facility inspections or those without prior export history may experience 60-90 day processing periods. Preliminary document review takes 7-10 days; incomplete applications must be re-submitted, extending timelines accordingly.

What happens if my manufacturing license expires while my API Certification is valid?

API Certification becomes automatically invalid if the underlying manufacturing license expires, lapses, or is suspended by the State Drugs Controller. You must immediately notify DGFT through the ITMS portal and discontinue exports. Continuing exports with expired manufacturing license violates the Drugs and Cosmetics Act 1940 and invites criminal prosecution under Section 27.

API Certification

Get API Certification for pharmaceutical exports from India via DGFT. Understand GMP requirements, eligibility, application process, fees, and renewal timelines.

Verify IEC registration and manufacturing license validity through CBIC and State Drugs Controller databases
Obtain GMP certification or equivalent quality audit report from recognized international certification bodies
Register on DGFT ITMS portal with company PAN, IEC, and basic organizational details
Prepare and upload manufacturing license, GMP certificate, quality manuals, product dossiers, and testing lab credentials
Submit application through ITMS with processing fee payment; await preliminary document review (7-10 days)

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What is API Certification?

API (Active Pharmaceutical Ingredient) Certification is a mandatory compliance document required for exporters of pharmaceutical raw materials and bulk drugs from India. This certification, issued by the Directorate General of Foreign Trade (DGFT) under the Ministry of Commerce & Industry, confirms that the API manufacturer meets specified quality, manufacturing, and regulatory standards mandated under the Pharmaceuticals Export Promotion Council (PEPCIndia) guidelines and the Foreign Trade (Development & Regulation) Act, 1992 (FTDR Act).

API Certification serves as proof of regulatory compliance and manufacturing excellence, enabling exporters to access international markets where importing countries require certified suppliers. The certification validates adherence to Good Manufacturing Practice (GMP) standards, product quality specifications, and documentation requirements essential for cross-border pharmaceutical trade under the FTP 2023-28.

Pricing

Package	Price	Details
Standard	On request	Including document prep

Process

📋
Verify IEC registration and manufacturing license validity through CBIC and State Drugs Controller databases
🔍
Obtain GMP certification or equivalent quality audit report from recognized international certification bodies
📝
Register on DGFT ITMS portal with company PAN, IEC, and basic organizational details
✅
Prepare and upload manufacturing license, GMP certificate, quality manuals, product dossiers, and testing lab credentials
📤
Submit application through ITMS with processing fee payment; await preliminary document review (7-10 days)
🏆
Attend facility inspection if notified by DGFT to verify GMP compliance and testing infrastructure
🤝
Receive API Certification with unique reference number via digital certificate upon final approval

Documents Required

Valid Importer-Exporter Code (IEC) registration certificate issued by CBIC
Pharmaceutical manufacturing license (Schedule M) issued by State Drugs Controller with validity proof
WHO-GMP, ISO 9001:2015, or equivalent certification from recognized auditing bodies (valid for minimum 1 year)
Comprehensive quality assurance manual, standard operating procedures (SOPs), and batch record documentation samples
Product dossiers for each API (composition, specifications, testing parameters, certificates of analysis)
NABL accreditation certificate or third-party testing lab affiliation letter for API quality testing
PAN certificate, GST registration, and company incorporation documents
FDA Form 356H and/or EMA CTD documentation (for APIs destined to regulated markets)
Compliance affidavit confirming no pending actions under FTDR Act, Customs Act 1962, or Drugs and Cosmetics Act
Audited financial statements (last 2 years) and export shipment records demonstrating manufacturing continuity

Frequently Asked Questions

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API Certification

Get API Certification for pharmaceutical exports from India via DGFT. Understand GMP requirements, eligibility, application process, fees, and renewal timelines.

Verify IEC registration and manufacturing license validity through CBIC and State Drugs Controller databases

Obtain GMP certification or equivalent quality audit report from recognized international certification bodies

Prepare and upload manufacturing license, GMP certificate, quality manuals, product dossiers, and testing lab credentials

Submit application through ITMS with processing fee payment; await preliminary document review (7-10 days)

Google VerifiedBusiness

500+Export Clients Served

End-to-EndEXIM Support

What is API Certification?

Package

Price

Details

Standard

On request

Including document prep

Process

📋

Verify IEC registration and manufacturing license validity through CBIC and State Drugs Controller databases

🔍

Obtain GMP certification or equivalent quality audit report from recognized international certification bodies

📝

✅

Prepare and upload manufacturing license, GMP certificate, quality manuals, product dossiers, and testing lab credentials

📤

Submit application through ITMS with processing fee payment; await preliminary document review (7-10 days)

🏆

Attend facility inspection if notified by DGFT to verify GMP compliance and testing infrastructure

🤝

Receive API Certification with unique reference number via digital certificate upon final approval

Documents Required

Valid Importer-Exporter Code (IEC) registration certificate issued by CBIC

Pharmaceutical manufacturing license (Schedule M) issued by State Drugs Controller with validity proof

WHO-GMP, ISO 9001:2015, or equivalent certification from recognized auditing bodies (valid for minimum 1 year)

Comprehensive quality assurance manual, standard operating procedures (SOPs), and batch record documentation samples

Product dossiers for each API (composition, specifications, testing parameters, certificates of analysis)

NABL accreditation certificate or third-party testing lab affiliation letter for API quality testing

PAN certificate, GST registration, and company incorporation documents

FDA Form 356H and/or EMA CTD documentation (for APIs destined to regulated markets)

Compliance affidavit confirming no pending actions under FTDR Act, Customs Act 1962, or Drugs and Cosmetics Act

Audited financial statements (last 2 years) and export shipment records demonstrating manufacturing continuity

Frequently Asked Questions