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GMP Certifications & Inspections shared on PharmaCompass

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Alkaloids Unit 1

Angelini Pharmaceuticals ACRAF

Anuh Pharma LTD

Bachem AG

Bachem Americas, Inc

Bachem Americas, Inc.

Bachem SA, Succursale de Vionnaz

Bio-gen Extracts Pvt. Ltd.

Bloomage Freda Biopharm Co.,Ltd.

CAD Middle East Pharmaceutical Industries LLC

Cebiphar

Century Pharmaceuticals

Changzhou Pharmaceutical Factory

Curtec International

Dabur Research Foundation

Deccan Nutraceuticals Pvt. Ltd.

Enaltec Labs Private Limited

Ethypharm

Eurofarma Laboratorios S.A.

Farbe Firma

Farmak A.S

Farmak A.S.

Global Pharmatech Pvt. Ltd

Heilen Biopharm Pvt. Ltd

Hiranya Cellulose Products

ICBio Clinical Research Pvt Ltd

Icrom SpA

Interquim SA

JQC Huayin Pharmaceutical Co Ltd

Jetpharma SA

Jiangsu Zhongbang Pharmaceutical Co, Ltd

Kangcare Bioindustry Co.,ltd

LAURUS LABS

Lusochimica SPA

MURLI KRISHNA PHARMA PVT LTD

Medichem Manufacturing Malta Ltd

Medichem S.A.

Meenaxy Pharma Pvt. Ltd

Megsan Labs Private Limited

Microchem SRL

Minakem High Potent

PIERRE FABRE

PMC Isochem

PROCOS S.p.A.

Peter Greven Nederland C.V

Phyton Biotech GmbH

Phyton Biotech LLC

Rafarm S.A

Ramdev Chemical Pvt Ltd

Reine Lifescience

SANLI ILAC

SM BIOMED SDN. BHD

Sai Tech Pharmaceuticals Pvt Ltd

Shenzhen Oriental Pharmaceutial Co.,Ltd

Shodhana Laboratories Ltd

Stellence Pharmscience Private Limited

Synnat Pharma Pvt. Ltd.

Titan Laboratories Pvt Ltd.

Trimax Bio Sciences (P) Limited

Unither Pharmaceuticals

VPL CHEMICALS PVT LTD

World Medicine Ilac San ve tic LTD STl

XL Laboratories Private Limited

zxcv

INSPECTION & REGISTRATION

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Health Canada: Inspection Start Date: 2016-05-20; Type- GMP Foreign
PMC Isochem is a subsidiary of PMC Group, a wholly owned subsidiary of PMC Group International Inc.,...
PMC Isochem is a subsidiary of PMC Group, a wholly owned subsidiary of PMC Group International Inc., which is an independent arm of PMC Group Inc. PMC Isochem offers CDMO services and catalog products for intermediates of APIs and active pharma ingredients, excipients and polymers based drug delivery solutions for major pharmaceutical companies worldwide to serve the needs of Oncology, Cardiovascular, Infectious, Gastro-Intestinal, Neurology and rare diseases. Gennevilliers, Pithiviers, and Vert-Le-Petit facilities close to Paris are all cGMP US-FDA audited.

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Health Canada: Inspection Start Date: 2014-01-10; Type- GMP Foreign
PMC Isochem is a subsidiary of PMC Group, a wholly owned subsidiary of PMC Group International Inc.,...
PMC Isochem is a subsidiary of PMC Group, a wholly owned subsidiary of PMC Group International Inc., which is an independent arm of PMC Group Inc. PMC Isochem offers CDMO services and catalog products for intermediates of APIs and active pharma ingredients, excipients and polymers based drug delivery solutions for major pharmaceutical companies worldwide to serve the needs of Oncology, Cardiovascular, Infectious, Gastro-Intestinal, Neurology and rare diseases. Gennevilliers, Pithiviers, and Vert-Le-Petit facilities close to Paris are all cGMP US-FDA audited.

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FDA-China: Approved
Bloomage Biotechnology Corporation Limited (formerly Bloomage Freda Biopharm), established by Blooma...
Bloomage Biotechnology Corporation Limited (formerly Bloomage Freda Biopharm), established by Bloomage International Investment Group, is a national High-Tech enterprise. Since 1990s, for the first time in China, developed fermentation procedure to manufacture Sodium Hyaluronate,Bloomage Biotech has devoted its efforts on research, development, and production in biotechnology field, not only on the innovation in Sodium hyaluronate, but also on relevant bioactive ingredients. As the raw material business unit, Bloomage Biotech Bioactive will keep providing innovative solutions and technical support to our valued partners.

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FDA-USA: Approved
Bloomage Biotechnology Corporation Limited (formerly Bloomage Freda Biopharm), established by Blooma...
Bloomage Biotechnology Corporation Limited (formerly Bloomage Freda Biopharm), established by Bloomage International Investment Group, is a national High-Tech enterprise. Since 1990s, for the first time in China, developed fermentation procedure to manufacture Sodium Hyaluronate,Bloomage Biotech has devoted its efforts on research, development, and production in biotechnology field, not only on the innovation in Sodium hyaluronate, but also on relevant bioactive ingredients. As the raw material business unit, Bloomage Biotech Bioactive will keep providing innovative solutions and technical support to our valued partners.

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MFDS- Korea: Approved
Bloomage Biotechnology Corporation Limited (formerly Bloomage Freda Biopharm), established by Blooma...
Bloomage Biotechnology Corporation Limited (formerly Bloomage Freda Biopharm), established by Bloomage International Investment Group, is a national High-Tech enterprise. Since 1990s, for the first time in China, developed fermentation procedure to manufacture Sodium Hyaluronate,Bloomage Biotech has devoted its efforts on research, development, and production in biotechnology field, not only on the innovation in Sodium hyaluronate, but also on relevant bioactive ingredients. As the raw material business unit, Bloomage Biotech Bioactive will keep providing innovative solutions and technical support to our valued partners.

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GMP Certificate-SD150009
Bloomage Biotechnology Corporation Limited (formerly Bloomage Freda Biopharm), established by Blooma...
Bloomage Biotechnology Corporation Limited (formerly Bloomage Freda Biopharm), established by Bloomage International Investment Group, is a national High-Tech enterprise. Since 1990s, for the first time in China, developed fermentation procedure to manufacture Sodium Hyaluronate,Bloomage Biotech has devoted its efforts on research, development, and production in biotechnology field, not only on the innovation in Sodium hyaluronate, but also on relevant bioactive ingredients. As the raw material business unit, Bloomage Biotech Bioactive will keep providing innovative solutions and technical support to our valued partners.

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FDA- USA:GMP Audit
With R&D, production and regulatory affairs all integrated on a single site we offer a complete rang...
With R&D, production and regulatory affairs all integrated on a single site we offer a complete range of CDMO services from early-stage development to scale-up & commercial manufacture of high potent APIs with occupational exposure limits (OEL) below to 0.1μg/m³/shift (OEB class 6) In trusted long-term partnerships, we enable pharmaceutical and biotechnological companies to develop and provide innovative treatments of the highest quality to their patients globally. Minakem High Potent is fully GMP compliant and FDA inspected production site that can also provide full regulatory support including the filing of regulatory dossiers.

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FAMHP- Belgium
With R&D, production and regulatory affairs all integrated on a single site we offer a complete rang...
With R&D, production and regulatory affairs all integrated on a single site we offer a complete range of CDMO services from early-stage development to scale-up & commercial manufacture of high potent APIs with occupational exposure limits (OEL) below to 0.1μg/m³/shift (OEB class 6) In trusted long-term partnerships, we enable pharmaceutical and biotechnological companies to develop and provide innovative treatments of the highest quality to their patients globally. Minakem High Potent is fully GMP compliant and FDA inspected production site that can also provide full regulatory support including the filing of regulatory dossiers.

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USFDA - 2016
FARMAK, a.s. is an exclusively Czech chemical and pharmaceutical company aimed at development, produ...
FARMAK, a.s. is an exclusively Czech chemical and pharmaceutical company aimed at development, production, and marketing of active pharmaceutical ingredients, intermediates and chemical specialities. The key factor for the company’s long-term performance lies in the production and marketing of active pharmaceutical ingredients. The company is heavily export-oriented with the most important export locations being the EU countries, the United States, India, Japan and Brazil. The company is also ready to support their customers with its extensive experience with contract manufacturing and development of the custom synthesis by our own R&D dept

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PMDA- Japan
FARMAK, a.s. is an exclusively Czech chemical and pharmaceutical company aimed at development, produ...
FARMAK, a.s. is an exclusively Czech chemical and pharmaceutical company aimed at development, production, and marketing of active pharmaceutical ingredients, intermediates and chemical specialities. The key factor for the company’s long-term performance lies in the production and marketing of active pharmaceutical ingredients. The company is heavily export-oriented with the most important export locations being the EU countries, the United States, India, Japan and Brazil. The company is also ready to support their customers with its extensive experience with contract manufacturing and development of the custom synthesis by our own R&D dept

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USFDA - 2018
FARMAK, a.s. is an exclusively Czech chemical and pharmaceutical company aimed at development, produ...
FARMAK, a.s. is an exclusively Czech chemical and pharmaceutical company aimed at development, production, and marketing of active pharmaceutical ingredients, intermediates and chemical specialities. The key factor for the company’s long-term performance lies in the production and marketing of active pharmaceutical ingredients. The company is heavily export-oriented with the most important export locations being the EU countries, the United States, India, Japan and Brazil. The company is also ready to support their customers with its extensive experience with contract manufacturing and development of the custom synthesis by our own R&D dept

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Health Canada: Inspection Start Date: 2016-10-05; Type- GMP Foreign
Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 ye...
Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.

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Health Canada: Inspection Start Date: 2015-09-11; Type- GMP Foreign
Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 ye...
Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.

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Health Canada: Inspection Start Date: 2014-06-16; Type- GMP Foreign
Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 ye...
Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.

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Health Canada: Inspection Start Date: 2013-01-07; Type- GMP Foreign
Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 ye...
Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.

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Health Canada: Inspection Start Date: 2016-10-18; Type- GMP Domestic - Regular Inspection
Phyton Biotech is the world's largest producer of taxane active pharmaceutical ingredients. The comp...
Phyton Biotech is the world's largest producer of taxane active pharmaceutical ingredients. The company produces Paclitaxel and Docetaxel through Plant Cell Fermentation (PCF(R)). These plant-derived products are used in the treatment of cancer and other life-threatening illnesses. Phyton was founded in 1990 in Ithaca, New York, and was acquired in 2003 by DFB Pharmaceuticals, a private Texas-based investment company. The company's manufacturing facilities are located in Ahrensburg, Germany and Delta, Canada.

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Health Canada: Inspection Start Date: 2014-10-07; Type- GMP Domestic - Initial Inspection
Phyton Biotech is the world's largest producer of taxane active pharmaceutical ingredients. The comp...
Phyton Biotech is the world's largest producer of taxane active pharmaceutical ingredients. The company produces Paclitaxel and Docetaxel through Plant Cell Fermentation (PCF(R)). These plant-derived products are used in the treatment of cancer and other life-threatening illnesses. Phyton was founded in 1990 in Ithaca, New York, and was acquired in 2003 by DFB Pharmaceuticals, a private Texas-based investment company. The company's manufacturing facilities are located in Ahrensburg, Germany and Delta, Canada.

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Health Canada: Inspection Start Date: 2014-03-20; Type- GMP Foreign
Phyton Biotech is the world's largest producer of taxane active pharmaceutical ingredients. The comp...
Phyton Biotech is the world's largest producer of taxane active pharmaceutical ingredients. The company produces Paclitaxel and Docetaxel through Plant Cell Fermentation (PCF(R)). These plant-derived products are used in the treatment of cancer and other life-threatening illnesses. Phyton was founded in 1990 in Ithaca, New York, and was acquired in 2003 by DFB Pharmaceuticals, a private Texas-based investment company. The company's manufacturing facilities are located in Ahrensburg, Germany and Delta, Canada.

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swissmedic- GMP
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a ful...
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide and oligonucleotide -based APIs. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Bachem shows total commitment.

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Health Canada: Inspection Start Date: 2015-06-17; Type- GMP Foreign
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a ful...
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide and oligonucleotide -based APIs. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Bachem shows total commitment.

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Health Canada: Inspection Start Date: 2014-11-03; Type- GMP Foreign
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a ful...
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide and oligonucleotide -based APIs. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Bachem shows total commitment.

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Health Canada: Inspection Start Date: 2014-11-03; Type- GMP Foreign
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a ful...
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide and oligonucleotide -based APIs. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Bachem shows total commitment.

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Health Canada: Inspection Start Date: 2013-01-22; Type- GMP Foreign
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a ful...
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide and oligonucleotide -based APIs. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Bachem shows total commitment.

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Health Canada: Inspection Start Date: 2012-04-24; Type- GMP Foreign
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a ful...
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide and oligonucleotide -based APIs. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Bachem shows total commitment.

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Health Canada: Inspection Start Date: 2012-04-16; Type- GMP Foreign
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a ful...
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide and oligonucleotide -based APIs. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Bachem shows total commitment.

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Health Canada: Inspection Start Date: 2012-01-09; Type- GMP Foreign
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a ful...
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide and oligonucleotide -based APIs. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Bachem shows total commitment.

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Health Canada: Inspection Start Date: 2017-05-29; Type- GMP Foreign
Interquim is integrated into the Ferrer HealthTech division and manufactures APIs. Our state-of-the-...
Interquim is integrated into the Ferrer HealthTech division and manufactures APIs. Our state-of-the-art installations are located in Sant Cugat del Valles. Our business is based on developing highly competitive processes for the manufacture of high added-value active pharmaceutical ingredients that meet the strictest quality specifications. Our products are manufactured under strict European environmental and work safety regulations. Our quality system and our installations have been inspected and approved by regulatory bodies and our clients, who demand the highest standards. Its products are sold in more than 70 countries.

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Health Canada: Inspection Start Date: 2016-05-02; Type- GMP Foreign
Interquim is integrated into the Ferrer HealthTech division and manufactures APIs. Our state-of-the-...
Interquim is integrated into the Ferrer HealthTech division and manufactures APIs. Our state-of-the-art installations are located in Sant Cugat del Valles. Our business is based on developing highly competitive processes for the manufacture of high added-value active pharmaceutical ingredients that meet the strictest quality specifications. Our products are manufactured under strict European environmental and work safety regulations. Our quality system and our installations have been inspected and approved by regulatory bodies and our clients, who demand the highest standards. Its products are sold in more than 70 countries.

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Health Canada: Inspection Start Date: 2015-10-29; Type- GMP Foreign
Interquim is integrated into the Ferrer HealthTech division and manufactures APIs. Our state-of-the-...
Interquim is integrated into the Ferrer HealthTech division and manufactures APIs. Our state-of-the-art installations are located in Sant Cugat del Valles. Our business is based on developing highly competitive processes for the manufacture of high added-value active pharmaceutical ingredients that meet the strictest quality specifications. Our products are manufactured under strict European environmental and work safety regulations. Our quality system and our installations have been inspected and approved by regulatory bodies and our clients, who demand the highest standards. Its products are sold in more than 70 countries.

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GMP Certificate (FDA Maharashtra State)
Fully owned subsidiary of Alkaloids Corporation, Kolkata (India), Factory located on a plot admeasur...
Fully owned subsidiary of Alkaloids Corporation, Kolkata (India), Factory located on a plot admeasuring 22,000 sq m and Started manufacturing in 2003. It Manufacture Herbal Extracts, Intermediates and APIs. All products are completely processed from start-to-finish in this plant. The premises has 4 (four) independent manufacturing blocks, in addition to a separate Warehouse, Quality Unit, Water Purification plant (potable/USP grade), Effluent Treatment Plant etc.

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Integrated Management Systems (IMS) Certificate
Synnat Pharma is dedicated to identification, development, production & distribution of potent Phyto...
Synnat Pharma is dedicated to identification, development, production & distribution of potent Phytochemicals and Botanical extracts. A number of Phytochemicals manufactured by Synnat are used as Active Pharmaceutical Ingredients by major drug formulators the world over. Manufacturing activity is carried out strictly as per ICH cGMP guidelines and several conventional and modern techniques are used for the isolation, semi-synthesis and purification of our products. The manufacturing processes have been validated to ensure consistent product quality.

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State GMP- Visakhapatnam
Synnat Pharma is dedicated to identification, development, production & distribution of potent Phyto...
Synnat Pharma is dedicated to identification, development, production & distribution of potent Phytochemicals and Botanical extracts. A number of Phytochemicals manufactured by Synnat are used as Active Pharmaceutical Ingredients by major drug formulators the world over. Manufacturing activity is carried out strictly as per ICH cGMP guidelines and several conventional and modern techniques are used for the isolation, semi-synthesis and purification of our products. The manufacturing processes have been validated to ensure consistent product quality.

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License Retention Certificate- L.Dis.No.294/AP/DCA/2018
Synnat Pharma is dedicated to identification, development, production & distribution of potent Phyto...
Synnat Pharma is dedicated to identification, development, production & distribution of potent Phytochemicals and Botanical extracts. A number of Phytochemicals manufactured by Synnat are used as Active Pharmaceutical Ingredients by major drug formulators the world over. Manufacturing activity is carried out strictly as per ICH cGMP guidelines and several conventional and modern techniques are used for the isolation, semi-synthesis and purification of our products. The manufacturing processes have been validated to ensure consistent product quality.