Metrochem API Private Limited | Others | Inspections & Registrations

Caplin Point Labs Acquires API Plant In Vizag From Metrochem API Private Limited

22 Nov 2022

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ERP company Focus Softnet find partners for growth in South India

23 Aug 2022

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Metrochem API Private Limited API Brochure Q1 Fy22-23

09 Jun 2022

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DATA COMPILATION
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DIGITAL CONTENT

1 INTERVIEW #SpeakPharma, 8 CORPORATE CONTENT #SupplierSpotlight, 1 COMPANY BIO #AboutSupplier, 16 NEWS #PharmaBuzz

media
1 INTERVIEW #SpeakPharma
8 CORPORATE CONTENT #SupplierSpotlight
1 COMPANY BIO #AboutSupplier
16 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

276 All APIs, 65 USDMF, 20 CEP/COS, 4 JDMF, 26 EU WC, 15 KDMF, 73 NDC API, 254 Listed APIs

276 All APIs
65 USDMF
20 CEP/COS
4 JDMF
26 EU WC
15 KDMF
73 NDC API
254 Listed APIs

KEY PRODUCTS

Abrocitinib, Alogliptin Benzoate, Cenobamate, Dapagliflozin, Dapagliflozin Propanediol Monohydrate, Edoxaban Tosylate, Lacosamide, Lasmiditan, Lurasidone Hydrochloride, Mavacamten, Nintedanib Esylate, Ranolazine, Relugolix, Ritlecitinib, Tapinarof, Vigabatrin, Vonoprazan Fumarate, Vortioxetine Hydrobromide, Zavegepant HCl

Abrocitinib
Alogliptin Benzoate
Cenobamate
Dapagliflozin
Dapagliflozin Propanediol Monohydrate
Edoxaban Tosylate
Lacosamide
Lasmiditan
Lurasidone Hydrochloride
Mavacamten
Nintedanib Esylate
Ranolazine
Relugolix
Ritlecitinib
Tapinarof
Vigabatrin
Vonoprazan Fumarate
Vortioxetine Hydrobromide
Zavegepant HCl

INSPECTIONS & REGISTRATIONS

2 FDA, 6 Others

inspections
2 FDA
6 Others

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

About

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers.

Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

CPhI Worldwide, MilanCPhI Worldwide, Milan

Industry Trade Show

Booth #3A33

08-10 October, 2024

Fiera Milano, Italy
IPEX IndonesiaIPEX Indonesia

Industry Trade Show

Attending

09-12 October, 2024

Jakarta, Indonesia
Pharmtech & Ingredient...Pharmtech & Ingredients

Industry Trade Show

Exhibiting

19-22 November, 2024

Crocus Expo, Pavilion 2, Moscow

CONTACT DETAILS

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Country

India

Address

The Watermark, 3rd floor & 4th floor, Plot No 11, Survey No. 9, Whitefields, K...

Telephone

+91 4069069999

webleads@metroapi.com

Website

https://www.metroapi.com/

https://in.linkedin.com/company/metrochem-api-pvt-ltd

Digital content

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INTERVIEW #SpeakPharma

“We are working towards providing affordable, high-quality APIs”

This week, SpeakPharma interviews Dr. N.V. Rao, Chairman and Managing Director of Hyderabad (India)-based Metrochem API, one of the fastest growing manufacturers of active pharmaceutical ingredients (APIs), pellets and intermediates. Dr. Rao talks about Metrochem API’s strong core values and how the company has put in special efforts to meet the needs of the under-cared and neglected communities, with a clear view on sustainable health for all.Can you briefly take us through Metrochem API’s journey? When we embarked on this extraordinary journey in 2004, armed with my expertise in organic chemistry, our vision was unwaveringly clear. We aimed to establish a company that would manufacture top-tier APIs of exceptional quality, all while maintaining cost-effectiveness. Our goal was to cater to the pharmaceutical industry's global needs and position Metrochem as the premier supplier of APIs to customers worldwide. Since our inception, we've strongly believed in creating value through vertical integration. This belief has driven us to continuously invest in infrastructure and manpower, ensuring an abundant supply of key starting materials (KSMs), intermediates, and essential raw materials. Our six state of the art manufacturing facilities are designed and operated in line with this risk mitigation vision. We consider ourselves a pure-play API manufacturing company with an acute awareness of the technical challenges facing the healthcare industry. Our focus has always been on expanding our product portfolio to meet the diverse demands and challenges of the global landscape. We've successfully built a robust product portfolio comprising over 190 products spanning more than 30 distinct therapeutic segments. We excel in handling a variety of niche products that require intricate chemical processes and pose significant challenges, elevating them beyond the typical niche category. Metrochem's journey, from my perspective, has been a relentless pursuit of excellence, innovation, and a commitment to serving the global pharmaceutical industry with integrity and dedication. What are some of the key reasons behind Metrochem API’s success?Our success is credited to our culture, which is founded on innovation, integrity, customer-centricity, and safety. These principles guide every Metrochem team member, and we take immense pride in consistently exceeding expectations.At Metrochem, our organization's foundation is built upon our core values, which we affectionately refer to as "LEADER." Within this framework, 'L' signifies our dedication to 'Learning aspiration,' 'E' embodies our perpetual pursuit of 'Excellence,' 'A' represents our 'Action-oriented' approach, 'D' symbolizes our commitment to 'Discipline,' 'E' underscores our steadfast dedication to 'Ethics and integrity,' and 'R' stands for 'Respect.'We maintain a strong commitment to ethical behavior and actively pursue our social responsibilities. We extend respect to every individual, and consider our stakeholders cherished members of our extended family. Building meaningful relationships with our customers, colleagues, and suppliers is an integral part of Metrochem's identity. These values are deeply ingrained within Metrochem, and guide our daily operations.This robust value system drives our passion for continual growth and self-improvement, both on an individual and at an organizational level. Our enthusiasm is channeled towards achieving operational excellence, with a primary focus on innovation and cost efficiency, all while upholding unwavering quality standards.How has your manufacturing setup grown over the years? Which regulatory authorities have recognized your efforts?Our journey began with a single API facility in Hyderabad, accredited with WHO-GMP, where we initially manufactured two APIs. By 2009, this facility had successfully met the rigorous regulatory standards set by the Pharmaceutical and Medical Devices Agency (PMDA) in Japan. In subsequent years, we not only maintained our WHO-GMP accreditation but also earned recognition from the US Food and Drug Administration (FDA) and COFEPRIS (Mexico Health Authority) in 2013. In 2014, we obtained accreditation from the Korea Food and Drug Administration (KFDA), which is now known as the MFDS (Ministry of Food and Drug Safety).We prioritize adhering to strict regulatory compliance standards. Our commitment is demonstrated through our willingness to undergo regular inspections by esteemed international and national regulatory authorities, including the USFDA, PMDA, WHO-GMP, ANVISA (Brazilian health regulator), and the European Directorate for the Quality of Medicines and Healthcare (EDQM), among other reputable bodies. These recognitions have played a pivotal role in elevating our position as a leading bulk drug manufacturer in India.We are grateful for the regulatory progress we have achieved over the years. At present, Metrochem has submitted 56 US Drug Master Files (USDMFs), 21 Certificates of Suitability (CEPs), and numerous other significant regulatory filings. Notably, we earned the global top ranking for the number of API USDMFs filed in 2022.We currently operate with six state-of-the-art manufacturing facilities located in the states of Telangana and Andhra Pradesh, boasting of a total reactor volume exceeding 3000KL. These manufacturing plants are backed by three cutting-edge, centrally located research and development laboratories, along with a pilot plant designated for testing and development purposes.What are Metrochem API’s target markets? How do you contribute towards sustainable healthcare?Currently, we are fulfilling pharmaceutical needs across over 60 countries. Unlike the typical focus on developed markets, our dedication extends to addressing healthcare inequalities not only in developed markets but also in the underserved, marginalized communities, and less developed nations. Our overarching vision centers on promoting sustainable access to healthcare for everyone.Our partners often say that “quality and affordability go hand in hand at Metrochem”. This has been possible due to our vertically integrated supply chain and our robust manufacturing process that we establish during the initial stages of product development. These processes allow us to not only match the desired specifications of our customers but also give us ample space to stay reasonable in terms of pricing, without hampering the quality standards.We have a wide-reaching market presence that covers diverse geographical regions, including India, the United States, Europe, South East Asia, the Middle East, Africa, Latin America, as well as Asian countries like Japan, Korea, China, Pakistan, Bangladesh, Nepal, and Sri Lanka. Our goal is to transform into a multinational company, from being a multi-state player, in the near future by setting up centers in crucial global locations. This strategic move will give us a substantial advantage in expanding our global presence and operations.We acknowledge our responsibility in promoting global health equity, which serves as a driving force for us to continuously enhance access to life-saving medications worldwide by aligning with varied rigorous delivery schedules.What are Metrochem API’s growth plans?Our objective is to become the foremost choice as an API supply chain partner. We plan to broaden our customer base through exceptional product quality and delivery services. At the same time, we aim to strengthen our global reputation as the most respected API partner, while diversifying our product portfolio to include candidates among varied therapeutic segments.In addition to having a product portfolio covering 30 different therapeutic segments, we have taken steps to enter the field of oncology by establishing a dedicated facility for the production of oncology APIs. Furthermore, we plan to start manufacturing steroids and peptides soon. Our vision includes expanding into biopharmaceutical manufacturing within the next five years, all while maintaining our commitment to core small molecule API production.Our goal is to achieve sustainable growth and establish ourselves as a leader in bulk drugs, catering to various market segments. To achieve this objective, we are actively working on developing an agile operational system that is aligned with our goals.

Impressions: 2986

CORPORATE CONTENT #SupplierSpotlight

Product List 2023

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Additional Product List 2023

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APIs Under Development 2023

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Corporate Presentation

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India Pharma 2021 & India Medical Devices 2021

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India Pharma Bulk Drug Company of the Year Award 2020

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India Pharma Bulk Drug Company of the Year Award 2020

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Corporate Video

COMPANY BIO #AboutSupplier

View Metrochem API's portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem's R&D activities on PharmaCompass.

View Metrochem API's portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem's R&D activities on PharmaCompass.Q1. What is Metrochem API and what are its product offerings?Metrochem API is one of the fastest-growing Indian manufacturers of active pharmaceutical ingredients (APIs), pellets (semi-finished formulations) and intermediates. It provides customized volumes and quality products to its clients all over the world.The company has six dedicated manufacturing facilities for its three core product groups - active pharmaceutical ingredients (APIs), pelletization and intermediates. These facilities, along with a well-equipped, centralized R&D laboratory, allow it to meet the high volume demands of its clients.Metrochem API focuses on innovation across people, processes, products and technology through knowledge exchange and cross-functional collaboration. Its research center in Hyderabad has three fully functional laboratories along with an analytical laboratory. It provides custom research and custom synthesis services as well.Metrochem API's six manufacturing facilities are located in Hyderabad and Visakhapatnam, India. These manufacturing facilities have received approval from several international regulatory agencies such as the USFDA, WHO GMP, Cofepris, KFDA and PMDA.Metrochem API offers the following products:APIs - Metrochem API is one of the leading active pharmaceutical ingredient (API) producers in India. It has its own R&D center and has received international FDA approval. It provides a variety of active pharmaceutical ingredients in multiple therapeutic areas, including antiulceratives, antifungals, antidepressants, antihypertensives, antithrombotic, antihistaminic, antilipemic, antiarthritic, anti-inflammatory, antidiabetic, antibacterial and gastoprokinetic.Pellets - Metrochem API also offers pellets (semi-finished formulations) in multiple therapeutic areas, such as antiulceratives, anti-inflammatory, antihypertensive, antihyperlipidemic, antipsychotic, antiemetic, antithrombotic, antispasmodics, antiasthmatic, immunosuppressant, etc. It also offers blended, combination, taste-masking pellets and micro granules for direct compression.Intermediates- Metrochem API makes various intermediates, including N-Benzylaniline, Pyridine-2-carbaldehyde, 1-bromo-4-chlorobenzene, 2-Hydroxymethyl-4-(3- methoxypropoxy)-3- methylpyridine, etc.Q2. What R&D activities does Metrochem API focus on?Metrochem API's R&D and manufacturing facilities in India have been constructed to meet the highest quality requirements. Metrochem's R&D center conducts research on APIs and intermediates that involve multi-step synthesis. The company has a proven track record of implementing and developing processes and scaling them up from the lab (kilo) to the commercial level.Metrochem can create new products and meet the demands of life science companies all over the world because of its expertise in research, analytical technique development, synthesis of impurities, organic synthesis, multi-step synthesis, custom synthesis, scale-up and technology transfer.The research center at Metrochem complies with cGLP standards and is focused on organic synthesis, custom synthesis services, analytical research, etc. The primary R&D activities of Metrochem API includes the development of active pharmaceutical ingredients (APIs), advanced intermediates and fine chemicals, with continuous process improvement for cost reduction and the long-term sustainability of its various businesses.Metrochem API offers the technical know-how and cutting-edge equipment necessary to develop analytical techniques for assessing the quality of raw materials, advanced intermediates and finished products. With the use of sophisticated instruments like GC-MS/MS, multi nuclei NMR, preparative HPLC, HPLCs with detectors like UV, RI, and PDA, and GCs, it is capable of analyzing the impurity profiles and identifying degradation products in their active compounds.The research center in Hyderabad contains three completely equipped laboratories and a well-equipped analytical laboratory spread across a 1,000 sq. meter area. Custom synthesis at Metrochem API is designed to satisfy the requirements of its customers, be they in the laboratory scale-up, commercial scale-up or post-commercialization stages. Metrochem API provides its extensive services along with a guarantee of quality and reliability. These are made available at a rate and cost that are beneficial to both parties.Q3. Where are Metrochem's manufacturing sites located and what is their regulatory inspection history?Metrochem API has emerged as one of India's fastest-growing pharmaceutical organizations. It has six cutting-edge production facilities situated in Hyderabad and Visakhapatnam, India. It has specialized manufacturing facilities for the production of APIs, pellets (semi-finished formulations) & intermediates, which are supported by a well-equipped, centralized research & development laboratory.Metrochem's manufacturing facilities have been approved by several international regulatory bodies such as ISO 9001-2015, USFDA, WHO GMP, Cofepris, as well as PMDA. The facilities have also been inspected by KFDA.The details about some of Metrochem's production units are as follows:Unit I for APIs - It is a dedicated facility located in Hyderabad, India, specializing in the production of active pharmaceutical ingredients (APIs). The facility has ISO 9001:2015, PMDA, WHO GMP and local GMP certification.The site spans across an area of 1006.25 sq. meters and comprises 10 reactors with a total volume of 30 KL. The facility also includes Class 100000 areas, consisting of 176.00 sq. meters for pharma grade manufacturing and 5.55 sq. meters for sampling and dispensing.Unit II for Pellets - The facility is located in Hyderabad, India, and is a dedicated site for the production of pellets (Semi-finished formulations). The facility has ISO 9001:2015, WHO-GMP and local GMP certification.The site spans an area of 1300.00 square meters and has a total of 13 FBC reactors with a capacity of 6,020 Kgs FBCV. Additionally, there are two Class 100000 areas within the facility., covering a manufacturing area of 634.00 sq. meters, while the sampling & dispensing area covers 8.43 sq. meters.Unit B for Intermediates - This facility is located in Sangareddy, India, and is solely devoted to the production of advanced Intermediates. The facility has received an accreditation of ISO 9001:2015.The site is spread over approximately 6.0 acres and has four reactors, including five GLRS and 35 SSRs, with a total volume capacity of 130 KL. The facility also has one class 100000 area.Unit C for Intermediates - This facility is also situated in Sangareddy, India, and is dedicated to the production of intermediates. The facility has received accreditations from ISO 9001:2015 and USFDA.The site is spread across an area of 26,040 sq. meters and houses 58 reactors (G-14 and SSR-44), with a total volume capacity of 237.101 KL. The facility also includes Class 100000 areas, including a sampling & dispensing area covering 2.86 sq. meters.Unit IV for APIs & Intermediates - Situated in Visakhapatnam, India, this facility is dedicated to the production of APIs & intermediates. It has ISO 9001:2015 and Schedule-M GMP certifications.The site occupies a total area of 386.50 meters and has 129 reactors with a total volume capacity of 715.53 KL. The facility also includes 11 Class 100000 areas, including the manufacturing area and sampling & dispensing area.Q4. What is Metrochem API's approach to environmental sustainability, and how does the company demonstrate its commitment to environmental management?Metrochem API is a responsible manufacturer of active pharmaceutical ingredients (APIs) and advanced intermediates that recognises and values environmental management as one of its top corporate priorities. It operates all aspects of its business as a responsible steward of the environment.According to Metrochem, environmental management must incorporate the principles and practices for protecting the environment, decreasing pollution and conserving natural resources. It believes companies should comply with the relevant laws and regulations and should be committed towards continual improvement.Metrochem API is committed to environmental sustainability and has made it one of its top corporate priorities. The company adheres to relevant laws and regulations and continuously strives for improvement.Metrochem API has established a framework for setting environmental objectives and targets, which are implemented, documented and communicated to all personnel in the organization. Additionally, Metrochem makes its environmental policy available to the public.

Impressions: 1877

NEWS #PharmaBuzz