EU GMP Certification
European Union GMP Competent Authority
Certificate on file
Unlocks Europe / EU export (SRA) market
View accreditation details
- Scope
- EU-GMP compliance for sterile injectables
- Site
- Tarapur, Maharashtra
-
1994
生产始于
-
15 +
国际认证
-
40 +
供应国家数
认证登记表
15+项认证，一座生产厂区
Naprod的Tarapur厂区持有15+项国际生产认证。登记册中的每一条记录，均在存档证书载明处标注颁证机构、认证范围、厂区及有效期；仍在数字化整理中的条目，将相应标注，直至完整详情发布。
-
-
ANVISA GMP Certification
ANVISA (Brazil)
Certificate on fileUnlocks Brazil / Mercosur supplyView accreditation details
- Scope
- GMP certification for sterile oncology injectables
- Site
- Tarapur, Maharashtra
- Issued
- Jan 2026
- Valid until
- Jun 2027
-
INVIMA GMP Certification
INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)
Certificate on fileUnlocks Colombia / Andean region supplyView accreditation details
- Scope
- GMP + GLP certification (INVIMA)
- Site
- Tarapur, Maharashtra
- Issued
- 2023
-
EAEU GMP Certificate
Eurasian Economic Union (EAEU) GMP
Certificate on fileUnlocks EAEU markets: Russia, Belarus, Kazakhstan, Armenia, KyrgyzstanView accreditation details
- Scope
- EAEU GMP certificate for sterile injectables
- Site
- Tarapur, Maharashtra
- Issued
- Jun 2026
-
UAE MOHAP Registration
UAE Ministry of Health and Prevention (MOHAP)
Certificate on fileUnlocks UAE / GCC supplyView accreditation details
- Scope
- Manufacturing site registration (MOHAP)
- Site
- Tarapur, Maharashtra
-
WHO-GMP Certification
World Health Organization GMP Certification Scheme
Certificate on fileUnlocks WHO-regulated tenders: UN agencies, Global Fund, ROW export marketsView accreditation details
- Scope
- GMP certification, compliance with WHO GMP guidelines for sterile and non-sterile pharmaceutical manufacturing
- Site
- Tarapur, Maharashtra
- Valid until
- Apr 2028
-
CDSCO / State FDA Manufacturing Licence
CDSCO / Maharashtra FDA (India)
Certificate on fileUnlocks India: domestic manufacture & wholesale (Schedule M / WHO-GMP)View accreditation details
- Scope
- Manufacturing (Form 28B, Schedule X) & wholesale (Form 20B/21B) licences; national WHO-GMP
- Site
- Tarapur, Maharashtra
- Valid until
- Dec 2027
-
NAFDAC GMP Certification
National Agency for Food and Drug Administration and Control (NAFDAC)
Being digitizedUnlocks Nigeria / West Africa supplyDocumentation being digitized. Full scope and validity to follow.
-
PPB GMP Certification
Pharmacy and Poisons Board (PPB)
Certificate on fileUnlocks Kenya / East Africa supplyView accreditation details
- Scope
- GMP certification (PPB Kenya)
- Site
- Tarapur, Maharashtra
-
TFDA GMP Certification
Tanzania Food and Drugs Authority (TFDA)
Certificate on fileUnlocks Tanzania / East Africa supplyView accreditation details
- Scope
- GMP approval (TFDA), doc 1110719783
- Site
- Tarapur, Maharashtra
-
NDA GMP Certification
National Drug Authority (NDA)
Certificate on fileUnlocks Uganda / East Africa supplyView accreditation details
- Scope
- GMP certification (NDA Uganda)
- Site
- Tarapur, Maharashtra
-
MCAZ GMP Certification
Medicines Control Authority of Zimbabwe (MCAZ)
Certificate on fileUnlocks Zimbabwe / Southern Africa supplyView accreditation details
- Scope
- Manufacturer approval (MCAZ)
- Site
- Tarapur, Maharashtra
-
FMHACA GMP Certification
Food, Medicine and Healthcare Administration and Control Authority (FMHACA)
Certificate on fileUnlocks Ethiopia / East Africa supplyView accreditation details
- Scope
- GMP certification (FMHACA / EFDA)
- Site
- Tarapur, Maharashtra
-
PMRA GMP Certification
Pharmacy and Medicines Regulatory Authority (PMRA)
Certificate on fileUnlocks Malawi / Southern Africa supplyView accreditation details
- Scope
- cGMP certification
- Site
- Tarapur, Maharashtra
-
PRA GMP Certification
Pharmaceutical Regulatory Authority (PRA)
Being digitizedUnlocks Zambia / Southern Africa supplyDocumentation being digitized. Full scope and validity to follow.
-
DPM GMP Certification
Direction de la Pharmacie et du Médicament (DPM)
Being digitizedUnlocks Côte d'Ivoire / Francophone West Africa supplyDocumentation being digitized. Full scope and validity to follow.
-
FDB GMP Certification
Food and Drugs Board (FDB)
Being digitizedUnlocks Ghana / West Africa supplyDocumentation being digitized. Full scope and validity to follow.
-
NHRA GMP Certification
National Health Regulatory Authority (NHRA)
Certificate on fileUnlocks Bahrain / Gulf supplyView accreditation details
- Scope
- GMP + manufacturing site registration (NHRA)
- Site
- Tarapur, Maharashtra
- Valid until
- Jan 2028
-
BPOM GMP Certification
Badan Pengawas Obat dan Makanan (BPOM)
Being digitizedUnlocks Indonesia supplyDocumentation being digitized. Full scope and validity to follow.
-
Yemen GMP Certification
Supreme Board of Drugs & Medical Appliances (SBDMA), Yemen
Certificate on fileUnlocks Yemen / MENA supplyView accreditation details
- Scope
- GMP certification
- Site
- Tarapur, Maharashtra
-
DIGEMID GMP Certification
DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)
Being digitizedUnlocks Peru / Andean region supplyDocumentation being digitized. Full scope and validity to follow.
Group company
MacChem: API manufacturing accreditations
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.
-
EDQM Certificate of Suitability (CEP)
European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe
Certificate on fileUnlocks EU API market: Certificate of Suitability (CEP)View accreditation details
- Scope
- CEP 2012-025 (Suxamethonium Chloride); EDQM inspection Oct 2023, attestation Mar 2024
- Site
- MIDC Tarapur, Boisar
-
Swissmedic GMP Compliance Certificate
Swissmedic, the Swiss Agency for Therapeutic Products
Certificate on fileUnlocks Switzerland / EU (EU–Switzerland MRA) API supplyView accreditation details
- Scope
- GMP compliance certificate CH23-0006 (Suxamethonium Chloride); inspection Oct 2023
- Site
- MIDC Tarapur, Boisar
- Issued
- Feb 2024
-
WHO-GMP Certificate
CDSCO / Maharashtra FDA (WHO-GMP format)
Certificate on fileUnlocks WHO-regulated tenders & ROW API export, 109 approved productsView 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
-
CDSCO Written Confirmation (EU API export)
Central Drugs Standard Control Organisation (CDSCO), India
Certificate on fileUnlocks EU API export: Written Confirmation (Art. 46b(2)(b), Dir. 2001/83/EC)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
-
ISO 14001:2015 & ISO 45001:2018
Bureau Veritas Certification (UKAS accredited)
Certificate on fileUnlocks Environmental & occupational health-and-safety management systemsView 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
-
Maharashtra FDA GMP Certificate
Food & Drugs Administration, Maharashtra State (India)
Certificate on fileUnlocks India manufacture: Bulk Drugs / API (Schedule M)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
市场准入
每一项认证都是通往特定市场的钥匙
法规事务团队将本登记表视为市场准入地图，而非荣誉墙。这些认证分为三条路径：严格监管机构（SRA）出口、其他海外出口，以及国内供应。
-
SRA与欧盟出口。
EU-GMP是打开欧盟出口市场的钥匙，也是本登记表中严格监管机构类别的关键认证。该证书由欧盟GMP主管机构颁发，已凭在档证书确认。
-
其他海外市场覆盖。
WHO-GMP支持WHO监管招标、联合国机构采购、全球基金，以及要求该认证的其他海外出口市场。ANVISA打开巴西及南方共同市场（Mercosur）贸易，INVIMA打开哥伦比亚及安第斯地区市场，EAEU GMP打开欧亚经济联盟市场（俄罗斯、白俄罗斯、哈萨克斯坦、亚美尼亚与吉尔吉斯斯坦），而UAE MOHAP与NHRA Bahrain则打开海湾地区供应。
-
国内供应。
来自CDSCO与马哈拉施特拉邦FDA的印度国内生产与批发许可，构成本登记表国内路径的基础，涵盖印度境内的生产与批发供应。
每份证书均针对Tarapur厂区的质量体系与工艺控制而颁发，本身并不构成对任何单一产品的批准；每个产品的具体注册，仍需依赖各自在相应市场提交并维护的注册档案。
目前已详细披露
已凭在档证书确认
巴西国家卫生监督局（Agência Nacional de Vigilância Sanitária，即ANVISA）已于2026年1月为Tarapur厂区续期GMP认证，证书有效期至2027年6月，覆盖无菌肿瘤注射剂生产。此次续期由Pharma India Magazine报道。WHO-GMP认证由世界卫生组织GMP认证体系颁发，覆盖Tarapur厂区的无菌与非无菌药品生产，是Naprod参与WHO监管招标及其他海外出口的基础。EU-GMP认证由欧盟GMP主管机构颁发，为Tarapur厂区的无菌注射剂打开欧盟出口市场。以上三项均属于已凭在档证书确认的认证，均标明颁证机构、范围、厂区及有效期详情；其余条目的完整文档，将随整理完成陆续在本页面发布。
药物警戒
产品投诉与安全报告
经销商、法规事务联系人及医疗专业人员，均可通过Contact页面维护的药物警戒与产品投诉渠道，报告与Naprod或MacChem生产产品相关的产品质量投诉或疑似不良事件。每一份报告都会被记录并分级处理，若涉及已上市产品，将转交该市场对应的法规事务负责人处理。Naprod不对已上市产品的安全性或有效性作出任何声明，本页面亦不暗示此类声明；本页所述的认证与投诉处理内容，仅描述生产质量体系与工艺控制。
Pending approval Named quality-management-system framework and pharmacovigilance SOP references are pending company confirmation and are not published here until verified.