موقع واحد للحقن المعقمة، دقّقته 21 جهة عبر ست مناطق.

تحمل منشأة Naprod في Tarapur 21 اعتمادًا دوليًا للتصنيع. تم تأكيد 15 منها من الشهادة الصادرة المحفوظة في الملف، ولكل منها الجهة المُصدرة، والنطاق، والموقع، والصلاحية حيثما تنص عليها الشهادة. أما الستة المتبقية فمؤكدة في السجل الداخلي للشركة، وهي قيد الرقمنة للنشر بالمستوى ذاته من التفصيل: الجهة المُصدرة، ونطاق الشهادة، والصلاحية الحالية.

21 accreditations on record · 15 detailed today · 6 being digitized

• 

  EU GMP Certification

  European Union GMP Competent Authority

  Certificate on file

  Unlocks Europe / EU export (SRA) market

  View accreditation details

  View accreditation details

  Scope

  EU-GMP compliance for sterile injectables

  Site

  Tarapur, Maharashtra

  ×

  EU GMP Certification

  European Union GMP Competent Authority · European Union

  Scope

  EU-GMP compliance for sterile injectables

  Unlocks

  Europe / EU export (SRA) market

  Site

  Tarapur, Maharashtra

• 

  ANVISA GMP Certification

  ANVISA (Brazil)

  Certificate on file

  Unlocks Brazil / Mercosur supply

  View accreditation details

  View accreditation details

  Scope

  GMP certification for sterile oncology injectables

  Site

  Tarapur, Maharashtra

  Issued

  Jan 2026

  Valid until

  Jun 2027

  ×

  ANVISA GMP Certification

  ANVISA (Brazil) · Brazil

  Scope

  GMP certification for sterile oncology injectables

  Unlocks

  Brazil / Mercosur supply

  Site

  Tarapur, Maharashtra

  Issued

  Jan 2026

  Valid until

  Jun 2027

• 

  INVIMA GMP Certification

  INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)

  Certificate on file

  Unlocks Colombia / Andean region supply

  View accreditation details

  View accreditation details

  Scope

  GMP + GLP certification (INVIMA)

  Site

  Tarapur, Maharashtra

  Issued

  2023

  ×

  INVIMA GMP Certification

  INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) · Colombia

  Scope

  GMP + GLP certification (INVIMA)

  Unlocks

  Colombia / Andean region supply

  Site

  Tarapur, Maharashtra

  Issued

  2023

• 

  EAEU GMP Certificate

  Eurasian Economic Union (EAEU) GMP

  Certificate on file

  Unlocks EAEU markets: Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan

  View accreditation details

  View accreditation details

  Scope

  EAEU GMP certificate for sterile injectables

  Site

  Tarapur, Maharashtra

  Issued

  Jun 2026

  ×

  EAEU GMP Certificate

  Eurasian Economic Union (EAEU) GMP · Eurasian Economic Union

  Scope

  EAEU GMP certificate for sterile injectables

  Unlocks

  EAEU markets: Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan

  Site

  Tarapur, Maharashtra

  Issued

  Jun 2026

• 

  UAE MOHAP Registration

  UAE Ministry of Health and Prevention (MOHAP)

  Certificate on file

  Unlocks UAE / GCC supply

  View accreditation details

  View accreditation details

  Scope

  Manufacturing site registration (MOHAP)

  Site

  Tarapur, Maharashtra

  ×

  UAE MOHAP Registration

  UAE Ministry of Health and Prevention (MOHAP) · United Arab Emirates

  Scope

  Manufacturing site registration (MOHAP)

  Unlocks

  UAE / GCC supply

  Site

  Tarapur, Maharashtra

• 

  WHO-GMP Certification

  World Health Organization GMP Certification Scheme

  Certificate on file

  Unlocks WHO-regulated tenders: UN agencies, Global Fund, ROW export markets

  View accreditation details

  View accreditation details

  Scope

  GMP certification, compliance with WHO GMP guidelines for sterile and non-sterile pharmaceutical manufacturing

  Site

  Tarapur, Maharashtra

  Valid until

  Apr 2028

  ×

  WHO-GMP Certification

  World Health Organization GMP Certification Scheme · Global / WHO member states

  Scope

  GMP certification, compliance with WHO GMP guidelines for sterile and non-sterile pharmaceutical manufacturing

  Unlocks

  WHO-regulated tenders: UN agencies, Global Fund, ROW export markets

  Site

  Tarapur, Maharashtra

  Valid until

  Apr 2028

• 

  CDSCO / State FDA Manufacturing Licence

  CDSCO / Maharashtra FDA (India)

  Certificate on file

  Unlocks India: domestic manufacture & wholesale (Schedule M / WHO-GMP)

  View accreditation details

  View accreditation details

  Scope

  Manufacturing (Form 28B, Schedule X) & wholesale (Form 20B/21B) licences; national WHO-GMP

  Site

  Tarapur, Maharashtra

  Valid until

  Dec 2027

  ×

  CDSCO / State FDA Manufacturing Licence

  CDSCO / Maharashtra FDA (India) · India

  Scope

  Manufacturing (Form 28B, Schedule X) & wholesale (Form 20B/21B) licences; national WHO-GMP

  Unlocks

  India: domestic manufacture & wholesale (Schedule M / WHO-GMP)

  Site

  Tarapur, Maharashtra

  Valid until

  Dec 2027

• 

  NAFDAC GMP Certification

  National Agency for Food and Drug Administration and Control (NAFDAC)

  Being digitized

  Unlocks Nigeria / West Africa supply

  Documentation being digitized. Full scope and validity to follow.

• 

  PPB GMP Certification

  Pharmacy and Poisons Board (PPB)

  Certificate on file

  Unlocks Kenya / East Africa supply

  View accreditation details

  View accreditation details

  Scope

  GMP certification (PPB Kenya)

  Site

  Tarapur, Maharashtra

  ×

  PPB GMP Certification

  Pharmacy and Poisons Board (PPB) · Kenya

  Scope

  GMP certification (PPB Kenya)

  Unlocks

  Kenya / East Africa supply

  Site

  Tarapur, Maharashtra

• 

  TFDA GMP Certification

  Tanzania Food and Drugs Authority (TFDA)

  Certificate on file

  Unlocks Tanzania / East Africa supply

  View accreditation details

  View accreditation details

  Scope

  GMP approval (TFDA), doc 1110719783

  Site

  Tarapur, Maharashtra

  ×

  TFDA GMP Certification

  Tanzania Food and Drugs Authority (TFDA) · Tanzania

  Scope

  GMP approval (TFDA), doc 1110719783

  Unlocks

  Tanzania / East Africa supply

  Site

  Tarapur, Maharashtra

• 

  NDA GMP Certification

  National Drug Authority (NDA)

  Certificate on file

  Unlocks Uganda / East Africa supply

  View accreditation details

  View accreditation details

  Scope

  GMP certification (NDA Uganda)

  Site

  Tarapur, Maharashtra

  ×

  NDA GMP Certification

  National Drug Authority (NDA) · Uganda

  Scope

  GMP certification (NDA Uganda)

  Unlocks

  Uganda / East Africa supply

  Site

  Tarapur, Maharashtra

• 

  MCAZ GMP Certification

  Medicines Control Authority of Zimbabwe (MCAZ)

  Certificate on file

  Unlocks Zimbabwe / Southern Africa supply

  View accreditation details

  View accreditation details

  Scope

  Manufacturer approval (MCAZ)

  Site

  Tarapur, Maharashtra

  ×

  MCAZ GMP Certification

  Medicines Control Authority of Zimbabwe (MCAZ) · Zimbabwe

  Scope

  Manufacturer approval (MCAZ)

  Unlocks

  Zimbabwe / Southern Africa supply

  Site

  Tarapur, Maharashtra

• 

  FMHACA GMP Certification

  Food, Medicine and Healthcare Administration and Control Authority (FMHACA)

  Certificate on file

  Unlocks Ethiopia / East Africa supply

  View accreditation details

  View accreditation details

  Scope

  GMP certification (FMHACA / EFDA)

  Site

  Tarapur, Maharashtra

  ×

  FMHACA GMP Certification

  Food, Medicine and Healthcare Administration and Control Authority (FMHACA) · Ethiopia

  Scope

  GMP certification (FMHACA / EFDA)

  Unlocks

  Ethiopia / East Africa supply

  Site

  Tarapur, Maharashtra

• 

  PMRA GMP Certification

  Pharmacy and Medicines Regulatory Authority (PMRA)

  Certificate on file

  Unlocks Malawi / Southern Africa supply

  View accreditation details

  View accreditation details

  Scope

  cGMP certification

  Site

  Tarapur, Maharashtra

  ×

  PMRA GMP Certification

  Pharmacy and Medicines Regulatory Authority (PMRA) · Malawi

  Scope

  cGMP certification

  Unlocks

  Malawi / Southern Africa supply

  Site

  Tarapur, Maharashtra

• 

  PRA GMP Certification

  Pharmaceutical Regulatory Authority (PRA)

  Being digitized

  Unlocks Zambia / Southern Africa supply

  Documentation being digitized. Full scope and validity to follow.

• 

  DPM GMP Certification

  Direction de la Pharmacie et du Médicament (DPM)

  Being digitized

  Unlocks Côte d'Ivoire / Francophone West Africa supply

  Documentation being digitized. Full scope and validity to follow.

• 

  FDB GMP Certification

  Food and Drugs Board (FDB)

  Being digitized

  Unlocks Ghana / West Africa supply

  Documentation being digitized. Full scope and validity to follow.

• 

  NHRA GMP Certification

  National Health Regulatory Authority (NHRA)

  Certificate on file

  Unlocks Bahrain / Gulf supply

  View accreditation details

  View accreditation details

  Scope

  GMP + manufacturing site registration (NHRA)

  Site

  Tarapur, Maharashtra

  Valid until

  Jan 2028

  ×

  NHRA GMP Certification

  National Health Regulatory Authority (NHRA) · Bahrain

  Scope

  GMP + manufacturing site registration (NHRA)

  Unlocks

  Bahrain / Gulf supply

  Site

  Tarapur, Maharashtra

  Valid until

  Jan 2028

• 

  BPOM GMP Certification

  Badan Pengawas Obat dan Makanan (BPOM)

  Being digitized

  Unlocks Indonesia supply

  Documentation being digitized. Full scope and validity to follow.

• 

  Yemen GMP Certification

  Supreme Board of Drugs & Medical Appliances (SBDMA), Yemen

  Certificate on file

  Unlocks Yemen / MENA supply

  View accreditation details

  View accreditation details

  Scope

  GMP certification

  Site

  Tarapur, Maharashtra

  ×

  Yemen GMP Certification

  Supreme Board of Drugs & Medical Appliances (SBDMA), Yemen · Yemen

  Scope

  GMP certification

  Unlocks

  Yemen / MENA supply

  Site

  Tarapur, Maharashtra

• 

  DIGEMID GMP Certification

  DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

  Being digitized

  Unlocks Peru / Andean region supply

  Documentation being digitized. Full scope and validity to follow.

MacChem (MAC-CHEM PRODUCTS (INDIA) PVT. LTD.), the group's active-pharmaceutical-ingredient company, manufactures oncology and general APIs and sterile bulk from its own site at MIDC Tarapur, Boisar. It is a separate legal entity from Naprod, with its own accreditation register. These credentials support MacChem's API supply into the EU and WHO-regulated markets.

6 accreditations on record · all confirmed from certificates on file

• 

  EDQM Certificate of Suitability (CEP)

  European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe

  Certificate on file

  Unlocks EU API market: Certificate of Suitability (CEP)

  View accreditation details

  View accreditation details

  Scope

  CEP 2012-025 (Suxamethonium Chloride); EDQM inspection Oct 2023, attestation Mar 2024

  Site

  MIDC Tarapur, Boisar

  ×

  EDQM Certificate of Suitability (CEP)

  European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe · European Union

  Scope

  CEP 2012-025 (Suxamethonium Chloride); EDQM inspection Oct 2023, attestation Mar 2024

  Unlocks

  EU API market: Certificate of Suitability (CEP)

  Site

  MIDC Tarapur, Boisar

• 

  Swissmedic GMP Compliance Certificate

  Swissmedic, the Swiss Agency for Therapeutic Products

  Certificate on file

  Unlocks Switzerland / EU (EU–Switzerland MRA) API supply

  View accreditation details

  View accreditation details

  Scope

  GMP compliance certificate CH23-0006 (Suxamethonium Chloride); inspection Oct 2023

  Site

  MIDC Tarapur, Boisar

  Issued

  Feb 2024

  ×

  Swissmedic GMP Compliance Certificate

  Swissmedic, the Swiss Agency for Therapeutic Products · Switzerland

  Scope

  GMP compliance certificate CH23-0006 (Suxamethonium Chloride); inspection Oct 2023

  Unlocks

  Switzerland / EU (EU–Switzerland MRA) API supply

  Site

  MIDC Tarapur, Boisar

  Issued

  Feb 2024

• 

  WHO-GMP Certificate

  CDSCO / Maharashtra FDA (WHO-GMP format)

  Certificate on file

  Unlocks WHO-regulated tenders & ROW API export, 109 approved products

  View accreditation details

  View accreditation details

  Scope

  WHO-GMP certificate …/53330: lyophilised/powder injectables + cytotoxic & general APIs; 109 products

  Site

  MIDC Tarapur, Boisar

  Issued

  Jan 2025

  Valid until

  Jan 2028

  ×

  WHO-GMP Certificate

  CDSCO / Maharashtra FDA (WHO-GMP format) · Global / WHO member states

  Scope

  WHO-GMP certificate …/53330: lyophilised/powder injectables + cytotoxic & general APIs; 109 products

  Unlocks

  WHO-regulated tenders & ROW API export, 109 approved products

  Site

  MIDC Tarapur, Boisar

  Issued

  Jan 2025

  Valid until

  Jan 2028

• 

  CDSCO Written Confirmation (EU API export)

  Central Drugs Standard Control Organisation (CDSCO), India

  Certificate on file

  Unlocks EU API export: Written Confirmation (Art. 46b(2)(b), Dir. 2001/83/EC)

  View accreditation details

  View accreditation details

  Scope

  Written Confirmation WC-0275 for 35 APIs exported to the EU; valid 3 years from May 2024

  Site

  MIDC Tarapur, Boisar

  Issued

  May 2024

  ×

  CDSCO Written Confirmation (EU API export)

  Central Drugs Standard Control Organisation (CDSCO), India · India

  Scope

  Written Confirmation WC-0275 for 35 APIs exported to the EU; valid 3 years from May 2024

  Unlocks

  EU API export: Written Confirmation (Art. 46b(2)(b), Dir. 2001/83/EC)

  Site

  MIDC Tarapur, Boisar

  Issued

  May 2024

• 

  ISO 14001:2015 & ISO 45001:2018

  Bureau Veritas Certification (UKAS accredited)

  Certificate on file

  Unlocks Environmental & occupational health-and-safety management systems

  View accreditation details

  View accreditation details

  Scope

  ISO 14001:2015 (environment) & ISO 45001:2018 (OH&S) for API manufacturing & dispatch; Cert IND.24.2007/IM/U

  Site

  MIDC Tarapur, Boisar

  Issued

  Dec 2024

  Valid until

  Dec 2027

  ×

  ISO 14001:2015 & ISO 45001:2018

  Bureau Veritas Certification (UKAS accredited) · India

  Scope

  ISO 14001:2015 (environment) & ISO 45001:2018 (OH&S) for API manufacturing & dispatch; Cert IND.24.2007/IM/U

  Unlocks

  Environmental & occupational health-and-safety management systems

  Site

  MIDC Tarapur, Boisar

  Issued

  Dec 2024

  Valid until

  Dec 2027

• 

  Maharashtra FDA GMP Certificate

  Food & Drugs Administration, Maharashtra State (India)

  Certificate on file

  Unlocks India manufacture: Bulk Drugs / API (Schedule M)

  View accreditation details

  View accreditation details

  Scope

  GMP certificate 6134110 for Bulk Drugs / API; Forms 25 (KD/715) & 28 (KD/506)

  Site

  MIDC Tarapur, Boisar

  Issued

  Jun 2026

  Valid until

  May 2029

  ×

  Maharashtra FDA GMP Certificate

  Food & Drugs Administration, Maharashtra State (India) · India

  Scope

  GMP certificate 6134110 for Bulk Drugs / API; Forms 25 (KD/715) & 28 (KD/506)

  Unlocks

  India manufacture: Bulk Drugs / API (Schedule M)

  Site

  MIDC Tarapur, Boisar

  Issued

  Jun 2026

  Valid until

  May 2029

تقرأ فرق الشؤون التنظيمية هذا السجل بوصفه خريطة وصول إلى الأسواق، لا جدارية إنجازات. وتنقسم الاعتمادات إلى ثلاثة مسارات: تصدير الأسواق المنظمة الصارمة (SRA)، وتصدير بقية دول العالم، والتوريد المحلي.

• SRA وتصدير الاتحاد الأوروبي

  تفتح EU-GMP سوق تصدير الاتحاد الأوروبي، وهي مفتاح الأسواق المنظمة الصارمة في هذا السجل. والشهادة، الصادرة عن جهة مختصة بـGMP في الاتحاد الأوروبي، هي من ضمن الاعتمادات الـ15 المؤكدة من شهادات في الملف.

• الوصول إلى بقية دول العالم

  تدعم WHO-GMP المناقصات الخاضعة لتنظيم منظمة الصحة العالمية، ووكالات الأمم المتحدة، والصندوق العالمي، وأسواق تصدير بقية دول العالم التي تتطلبها. وتفتح ANVISA تجارة البرازيل والميركوسور، وتفتح INVIMA كولومبيا ومنطقة الأنديز، وتفتح شهادة EAEU GMP أسواق الاتحاد الاقتصادي الأوراسي (روسيا وبيلاروسيا وكازاخستان وأرمينيا وقيرغيزستان)، بينما تفتح UAE MOHAP وNHRA Bahrain التوريد إلى دول الخليج.

• التوريد المحلي

  ترسّخ تراخيص التصنيع والبيع بالجملة المحلية في الهند الصادرة عن CDSCO وMaharashtra FDA المسار المحلي في هذا السجل، وتغطي التصنيع والبيع بالجملة داخل الهند.

وتنحصر كل شهادة في أنظمة الجودة وضوابط العمليات الخاصة بموقع Tarapur. وهي لا تشكّل في حد ذاتها موافقة على أي منتج بعينه، ولا يزال كل تسجيل منتج قائم عليها يعتمد على تقديم ملفه التنظيمي الخاص والحفاظ عليه في تلك السوق.

جدّدت ANVISA، الوكالة البرازيلية الوطنية للرقابة الصحية (Agência Nacional de Vigilância Sanitária)، شهادة GMP لموقع Tarapur في يناير 2026، والشهادة صالحة حتى يونيو 2027 وتغطي تصنيع حقن الأورام المعقمة. وذكرت مجلة Pharma India Magazine خبر التجديد. وتغطي شهادة WHO-GMP، الصادرة بموجب مخطط اعتماد GMP التابع لمنظمة الصحة العالمية، تصنيع المستحضرات الصيدلانية المعقمة وغير المعقمة في Tarapur، وترتكز عليها مشاركة Naprod في المناقصات الخاضعة لتنظيم منظمة الصحة العالمية وتصدير بقية دول العالم. وتفتح شهادة EU-GMP، الصادرة عن جهة مختصة بـGMP في الاتحاد الأوروبي، سوق تصدير الاتحاد الأوروبي للحقن المعقمة في موقع Tarapur. وهذه الشهادات الثلاث من ضمن الاعتمادات الـ15 المؤكدة الآن من الشهادة الصادرة المحفوظة في الملف، ولكل منها تفاصيل الجهة المُصدرة، والنطاق، والموقع، والصلاحية؛ وتُنشر الوثائق الكاملة للإدخالات المؤكدة المتبقية في هذه الصفحة كلما اكتملت.

يمكن للموزعين وجهات الاتصال في الشؤون التنظيمية والعاملين في الرعاية الصحية الإبلاغ عن شكوى جودة منتج أو حدث سلبي مشتبه به مرتبط بمنتج مصنَّع من Naprod أو MacChem عبر مسار اليقظة الدوائية وشكاوى المنتجات المتاح في صفحة الاتصال. ويُسجَّل كل تقرير ويُصنَّف حسب الأولوية، وحيثما يتعلق بمنتج مسوَّق، يُحال إلى جهة الاتصال المسؤولة عن الشؤون التنظيمية في السوق المعنية. ولا تقدّم Naprod، ولا تُلمِّح هذه الصفحة إلى، أي ادعاء بشأن سلامة أو فعالية منتج مسوَّق؛ فالبيانات المتعلقة بالاعتماد ومعالجة الشكاوى هنا تصف أنظمة جودة التصنيع وضوابط العمليات فقط.

Pending approval Named quality-management-system framework and pharmacovigilance SOP references are pending company confirmation and are not published here until verified.