Top Empty Capsules Manufacturing Companies : Pharma CMOs

ACG Worldwide LogoQualicaps LogoHealthcaps India Ltd LogoErawat Pharma Limited LogoSuheung Capsule(Suheung Co., Ltd.) LogoCapsCanada LogoZhejiang Huili Capsules Co., Ltd. Logo

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Top API contract manufacturers in Mexico

Megafine Pharma (P) Ltd. LogoUQUIFA Logo

About Companies

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Megafine, established in 1995, is a privately owned and professionally managed enterprise with it’s corporate office in Mumbai and two multipurpose manufacturing sites at Vapi & Nashik in India, Vapi facility being successfully inspected by US-FDA and the Nashik facility is being approved by BGVFHH Germany (EMA EU-GMP), Japan PMDA, Health Canada, TGA Australia, COFEPRIS Mexico & Korea MFDS. Both the plants are also certified by WHO GMP, ISO 9001:2008, 14001:2004 & OHSAS 18001:2007 and have been audited by several Innovators and leading Generic companies from time to time.

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Uquifa is the API division of Vivimed Labs. Uquifa is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates for the pharmaceutical Industry. Operates 3 manufacturing sites, 2 in Spain and 1 in Mexico, which operates under cGMP conditions and has been inspected and approved by major Pharmaceutical Companies and Regulatory Authorities, including the US FDA. Uquifa sells to more than 70 countries worldwide and has more than 150 active DMF´s filed and 26 COS approved. Uquifa counts amongst its customers the major Generic and Ethical companies operating in the Industry and continues to invest in personnel and facilities to maintain a strong technology offering to both, the Generic Industry and the Ethical Pharmaceutical Industry. In addition to our stable generic portfolio, UQUIFA works as CMO, developing and producing Toll Manufacture and Custom Synthesis giving assistant to your business. Fulfilling regulatory and quality requirements to ensure your product is produced in in the same way as if you perform internally.

Top companies involved in micronization of APIs

MICRO-MACINAZIONE S.A. Now a Lonza Company LogoF.P.S. Food and Pharma Systems srl LogomiBEC (division of BEC Chemicals) LogoNeo-Advent Technologies, LLC LogoMUNIT SA Logo

Below is quick note about capabilities of these companies:

Neo-Advent Technologies LLC

Neo-Advent Technologies LLC offer a vast array of preclinical development services in drug formulation, analytical and bioanalytical characterization in support of pharmaceuticals, biopharmaceuticals and medical devices. The Company works with all drug forms with a particular expertise in micronization, milling and particle size reduction as well as drug delivery, polymer and biopolymers modifications and analysis. We run an integrated custom synthesis lab and a pilot production and purification suite.

MUNIT

MUNIT is a new and innovative consultancy company, operating in the field of MICRONIZATION of Active Pharmaceutical Ingredients (APIs), High Potent APIs, Cytotoxic and Cytostatic compounds, Inhalation products, Steroids, R&D compounds and Generics.

MICRO-MACINAZIONE S.A. Now a Lonza Company

With over 40 years of experience, swiss-based Micro-Macinazione S.A. is the most competent provider of Micronization services and equipment for the Pharmaceutical & Fine Chemical industry.

FPS Food and Pharma Systems

FPS Food and Pharma Systems is a leading company in the containment and micronization fields, developing, manufacturing and installing worldwide its own range of Milling and Micronization Systems and Containment Solutions (for both sterile and toxic applications).

Mi -BEC

Mi -BEC is a division of BEC Chemicals established in 2016, located at Mahape (Navi Mumbai). We are specialized in Micronization of Active Pharmaceutical Ingredients (API’s).

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Everything you need to know about ranking of global API suppliers

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API Contract Manufacturing

API, active pharmaceutical ingredient is key spend line item  for pharmaceutical companies. In order to have strategic alliance with right vendor, one should evaluate API manufacturing experience that each vendor carries. Best way to check API mfg strength of potential strategic vendors is by evaluating their US DMF count. Below is the list of top 10 US DMF holders in Type II category.

 

Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Company US DMF Count
TEVA or TAPI 311 ( website says 370 APIs )
MSN 266 ( website says 152 APIs )
AUROBINDO PHARMA 215 (SEC filings states 220 APIs)
MYLAN 213 ( website says 250 APIs )
DR REDDY 205 ( website says 450 + globally)
HETERO DRUGS 202
LUPIN 182
SUN PHARMA 160
CIPLA 156
CADILA 137

As expected, market was led by TAPI which holds close to 311 DMFs under Type II DMF category, followed by MSN, Aurobindo, Mylan & Dr Reddy.

Below are some important points from analysis:

  • Total of 10243 active DMF count were recorded in Type II DMF category.
  • Top 12 players accounted for ~23% of overall DMF count, with more than quarter of this 23% coming from Teva and MSN alone.
  • Only 5 companies accounted for greater than 2% of DMF count share, and included likes of Dr Reddy, Aurobindo Pharma, Mylan and two mentioned in above point.

DMF count might appear as just another number but it is one of the most important KPI to understand vendor’s technical know-how. Hence, the above mentioned vendors if part of your incumbent list, should be retained as is, and must be transitioned to strategic vendors going forward. If otherwise, these suppliers must be positioned in your preferred partner list, probably for future consignments mapped to large volumes.

Source 1 : http://www.msnlabs.com/api-dmfs.html

Source 2 : http://www.aurobindo.com/docs/press-room/press-reports/aurobindo-pharma-ltd-q4-fy-16-17-and-fy-1617-press-release.pdf

Source 3 : https://www.tapi.com/ProductCatalog.pdf?v=812

Source 4 : http://www.mylan.in/en/manufacturing-and-scientific-affairs/manufacturing/active-pharmaceutical-ingredients

Source 5 :http://www.drreddys-cps.com/apis-and-intermediates/commercial-supplies/

 

 

This API CMO is leaving no stone un-turned to gain competitive edge

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Cambrex Corporation (NYSE:CBM), one of the most prominent player in custom and branded API space announced that it will expand R&D capabilities at its site in Paullo, Milan, Italy. New facility would be spread across 150m² and would include new staff that company is likely to recruit in coming days. The move is targeted towards increasing the number of generic APIs in the company’s development portfolio.

Lab set up to include 14 fume hoods and will combine both chemistry and analytical development capabilities, with the installation of glass lined reactors, as well as analytical instruments including multiple high and ultra-performance liquid chromatography, and gas chromatography systems. While the construction of the R&D space would complete by end of 2018, instrument set up leading to operational and functional space would happen by Q1 2019.

Quotes from Company Officials

“The generic API industry is growing due to the continued expiry of product patents, which results in the constant flow of new generic entrants to the market,” commented Aldo Magnini, Managing Director, Cambrex Milan. “The new laboratory will increase the number of programs we can be active in at any one time, allowing us to expand our portfolio of generic products.”

Cambrex currently has 70 generic APIs in its kitty, which obviously carries cGMP tag. Milan site of Cambrex has seven  departments, supported by a pilot plant, kilo-scale plant and development and analytical laboratories.

Activities of API CMOs are on rise, ranging from alliances, M&A, capacity expansion and innovation. On this quest of being best in class API CMO addressing the need of pharma buyers, Cambrex is doing everything at its behest to have competitive edge.

Watch out for more update on API CMOs activities, investments and other strategic moves.

Image Source: Company Website

Data Sources: Company Website

Top Pharma API and Finished Dosage Formulators

Quick visualization of US FDA audited companies have been captured in info-graphics GDUFAbelow. Regulatory data have been used as feed stock for these deductions.

Trailblazers across various areas have been highlighted in visualization. Some of the major observations have been outlined below:

  1.  Year 2016 witnessed dip in overall FDA audited facility counts.
  2. While Sanofi led the FDA approved facility count in API space, Mylan was forerunner in finished dosage segment.
  3. India witnessed highest facility count increase in API space, while Taiwan enjoyed  number 1 position in terms of increase in FDF approved facilities for the year trailing 2016-2017.

Note: Analysis was carried on data sets which was not very organized at company name level, hence some of the prominent entries might be missing from visualization.